[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metformin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metformin":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,52,81,112,140,165,190,224,248,271,295,318,345],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100603043","interaction-between-inorganic-nitrate-supplementation-and-metformin-in-individuals-with-prediabetes-100603043",false,"NCT07131384","Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes","The Interaction Between Inorganic Nitrate Supplementation and Metformin on Exercise Capacity, Vascular Function, and Insulin Sensitivity in Individuals With Pre-Diabetes","NO3-PreDM","Inclusion Criteria:\n\n* Individuals who can communicate meaningfully with the investigator and can provide written consent.\n* Confirmed prediabetic individuals (ages 18-60 years old) (2-hour glucose of 140-199 mg\u002FdL following OGTT test or HbA1c between 5.7-6.4% tested on two occasions within 6 months).\n* Taking metformin (stable dose for at least a week) or naïve to metformin\n* Sedentary (\\\u003C1 day\u002Fweek of structured exercise)\n* Be able to perform exercise on a cycle ergometer without assistance\n* Stable medication regimen for the last 6 months\n* If female, have a normal menstrual cycle\n\nExclusion Criteria:\n\n* Estimated Glomerular filtration rate (GFR) ≤ 45\n* Body mass index ≥ 40 Kg\u002Fm2\n* HbA1c \\> 6.4%\n* Smokers within the last 5 years\n* Has experienced significant weight loss \\~3 kg in the last three months or is taking any weight loss drugs\n* Current medical condition that prohibits exercising at high intensities\n* Currently on hormone replacement of any kind\n* History of myocardial infarction, cerebrovascular event, acute or unstable disease other than pre-diabetes or obesity\n* Currently taking any of the following medications (calcium channel blockers, statins, ACE or renin inhibitors, angiotensin receptor blockers, organic nitrates (e.g., nitroglycerine) or recent regular use of inorganic nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, PDE-5 inhibitors (e.g.,: Cialis, Viagra), or xanthine oxidase inhibitors (e.g.,: Allopurinol))\n* Oral antibiotic use within the previous four weeks, including over-the-counter antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use\n* Oral cancer\u002Fsevere oral disease\n* Uncontrolled hypertension (\\>140\u002F90)\n* Had hysterectomy or oophorectomy\n* Fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking participants","ALL","18 Years","60 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is examining whether short-term supplementation with inorganic nitrate, in the form of beetroot juice, can enhance blood vessel health, insulin sensitivity, and exercise capacity in individuals with prediabetes. We will be comparing the responses in individuals who are taking metformin to those who are naive to metformin. The results from this study may help identify non-pharmacological interventions in prediabetes.",[28,29,30,31,32],"Males","Females","Sedentary","Metformin","Prediabetes",[34,35,36,37,38],"Prediabetic Individuals","Exercise Capacity","Vascular health","Inorganic nitrate","Insulin Sensitivity","RECRUITING","2026-06-02",{"date":42,"type":43},"2026-06-03","ACTUAL",{"date":45,"type":43},"2026-01-01",{"date":47,"type":22},"2027-06-30",{"name":49,"class":50},"University of Virginia","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":51},"100626480","phase-4-mitochondrial-redox-modulation-in-newly-diagnosed-type-2-diabetes-a-randomized-controlled-trial-comparing-imeglimin-vs-metformin-monotherapy-100626480","NCT07436182","Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. Metformin Monotherapy","MIRROR-DM",".1 Inclusion Criteria\n\nParticipants must meet ALL of the following criteria for enrollment:\n\n1. Age 18 or more inclusive, male or female.\n2. Confirmed diagnosis of T2DM within the preceding 12 months prior to screening, established by ADA or WHO criteria: fasting plasma glucose ≥ 126 mg\u002FdL on two separate occasions, and\u002For 2-hour OGTT plasma glucose ≥ 200 mg\u002FdL, and\u002For HbA1c ≥ 6.5%, and\u002For random plasma glucose ≥ 200 mg\u002FdL with classic hyperglycemic symptoms.\n3. HbA1c between 6.5% and 7.5 % inclusive at screening.\n4. Treatment-naive: no prior antidiabetic pharmacological treatment, or any prior antidiabetic treatment discontinued at least 3 months before screening.\n5. Estimated glomerular filtration rate (eGFR) ≥ 45 mL\u002Fmin\u002F1.73m² by CKD-EPI formula at screening.\n6. Willing and able to provide written informed consent in Arabic or English.\n7. Able to attend all scheduled study visits and comply with study procedures, dietary restrictions, and pre-analytical blood collection requirements.\n\n2 Exclusion Criteria\n\nParticipants meeting ANY of the following criteria will be excluded:\n\n1. Type 1 diabetes mellitus, Latent Autoimmune Diabetes in Adults (LADA), or other specific types of diabetes (anti-GAD antibody positivity, monogenic diabetes).\n2. HbA1c \\>7.5 gm%\n3. eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m² - increase risk of drug accumulation and lactic acidosis.\n4. Hepatic impairment defined as ALT or AST \\> 2.5 times the upper limit of normal at screening. Hepatic dysfunction independently elevates plasma lactate by impairing lactate clearance and pyruvate metabolism, confounding the primary endpoint.\n5. History of or current congestive heart failure (NYHA Class III-IV) or clinically significant cardiovascular disease with hemodynamic instability major risk factor for lactic acidosis and a confound for tissue lactate metabolism.\n6. Active or recent (within 3 months) use of any antidiabetic pharmacological agent.\n7. Current use of medications known to significantly affect mitochondrial function or lactate\u002Fpyruvate metabolism: valproate, linezolid, nucleoside reverse transcriptase inhibitors (NRTIs), phenformin, zidovudine, or high-dose thiamine-depleting regimens.\n8. Pregnancy, planned pregnancy within the trial period, or active breastfeeding.\n9. Active malignancy requiring chemotherapy, radiotherapy, or immunosuppression within the preceding 6 months.\n10. Significant chronic alcohol use: \\> 21 units per week (male) or \\> 14 units per week (female). Alcohol is a major independent confound for pyruvate\u002Flactate ratio through its own effects on hepatic NAD+\u002FNADH balance.\n11. Acute illness, surgery, trauma, or hospitalization within 4 weeks of screening, acute physiological stress elevates plasma lactate independent of drug effects.\n12. Vigorous or unaccustomed physical exercise within 24 hours of any biomarker blood draw, exercise-induced lactate elevation is a major pre-analytical confound.\n13. Known hypersensitivity or contraindication to imeglimin or metformin.\n14. Participation in another interventional clinical trial within 3 months preceding screening.\n15. Any condition that, in the investigator's judgment, would render the patient unable to safely complete the trial or reliably provide valid biomarker samples.",{"count":60,"type":22},176,[62],"PHASE4","he goal of this clinical trial is to compare the mitochondrial redox effects of imeglimin versus metformin monotherapy in adults with newly diagnosed Type 2 diabetes mellitus who are treatment-naive. The main questions it aims to answer are:\n\nDoes imeglimin improve the fasting plasma pyruvate\u002Flactate ratio (a validated surrogate of mitochondrial NAD⁺\u002FNADH redox balance) to a greater extent than metformin after 12 weeks of treatment? Does imeglimin produce more favorable changes in secondary mitochondrial and glycemic biomarkers - including fasting plasma lactate, fasting plasma pyruvate, HbA1c, HOMA-IR, and lipid profile - compared to metformin?\n\nResearchers will compare imeglimin 1000 mg twice daily to metformin up to 1000 mg twice daily to see if imeglimin produces superior improvement in mitochondrial oxidative capacity and cytoplasmic redox balance, reflected by a greater increase in the fasting plasma pyruvate\u002Flactate ratio, without compromising glycemic efficacy or safety.\n\nParticipants will:\n\nTake either imeglimin 1000 mg twice daily or metformin (titrated up to 1000 mg twice daily) orally for 12 weeks, as assigned by randomization Attend clinic visits at baseline (Week 0) and at Week 12 for fasting blood sample collection, including strict bedside deproteinization of pyruvate samples using ice-cold perchloric acid to ensure analytical accuracy Undergo measurement of fasting plasma pyruvate\u002Flactate ratio, HbA1c, HOMA-IR, fasting glucose, fasting insulin, fasting plasma lactate, fasting plasma pyruvate, and full lipid profile at both visits Be monitored for adverse events and safety parameters, including renal function (eGFR), throughout the study period",[65,31],"Mitochondria",[67,68,31,69,70],"type 2 diabetes","Imeglimin","Pyruvate\u002FLactate ratio","Mitochondrial redox","NOT_YET_RECRUITING","2026-02-21",{"date":74,"type":43},"2026-02-27",{"date":76,"type":22},"2026-03-01",{"date":78,"type":22},"2026-06-01",{"name":80,"class":50},"Mansoura University",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100279270","phase-4-investigation-of-metformin-in-pre-diabetes-on-atherosclerotic-cardiovascular-outcomes-100279270","NCT02915198","Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes","CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)","VA-IMPACT","Inclusion Criteria:\n\n1. Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg\u002FdL; or a 2-hour plasma glucose level of 140-199 mg\u002FdL following a 75 g glucose load oral glucose tolerance test.\n2. Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.\n\nCoronary artery disease is fulfilled by at least one of (1), (2), or (3):\n\n1. History of myocardial infarction at least one month prior to randomization.\n2. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.\n3. Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries.\n\nCerebrovascular disease is fulfilled by at least one of criteria (1) through (4):\n\n1. Documented prior ischemic stroke (at least one month prior to randomization),\n2. Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s),\n3. Asymptomatic carotid stenosis of at least 70% luminal diameter,\n4. History of carotid revascularization (surgical or catheter-based).\n\nPeripheral arterial disease: Fulfilled by at least one of the following:\n\n1. History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia,\n2. Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85.\n\n3\\. Renal function: Estimated glomerular filtration rate at least 45 mL\u002Fmin\u002F1.73 m2.\n\n4\\. Informed consent has been fully executed, and participant agrees to study procedures.\n\nExclusion Criteria:\n\n1. Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes, inpatient treatment with insulin or treatment with an SGLT2 inhibitor (e.g., for heart failure) or a GLP-1 receptor agonist (e.g., for obesity) is not exclusionary.\n2. Treatment with systemic glucocorticoids within 3 months of randomization\n3. Fasting plasma glucose greater than 130 mg\u002FdL measured between screening and randomization visits, or any plasma glucose 180 mg\u002FdL or HbA1c 7.0% measured within 12 months of randomization.\n4. Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel\n5. Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor.\n6. Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin \\> 2 times upper limit of normal\n7. Binge or heavy alcohol consumption within 6 months of randomization\n8. Severe anemia (hemoglobin \\\u003C 10 g\u002FdL)\n9. Prior history of intolerance to metformin\n10. Myocardial infarction, coronary revascularization procedure, or stroke within 1 month of randomization\n11. Uncontrolled hypertension at screening assessment (systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg\n12. Acute or decompensated congestive heart failure\n13. Expected survival less than study duration\n14. Participants considered to be unable, unwilling, or unreliable to meet protocol requirements\n15. Impaired decision-making capacity, defined by any history of dementia or cognitive impairment\n16. Concurrent participation in another research study involving a randomized comparison of drug or device treatments, unless specifically excepted.\n17. Pregnant, intent to become pregnant during the trial, or lactating\n18. Women of childbearing potential who are not using a highly effective method of contraception",{"count":90,"type":22},7410,[62],"This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and\u002For strokes in Veterans who have pre-diabetes and heart or blood vessel problems.",[94,95,31],"Prediabetic State","Atherosclerosis",[31,95,94,97,98,99,100],"Hemoglobin A, Glycosylated","Coronary Artery Disease","Peripheral Arterial Disease","Cerebrovascular Disorders","2025-12-12",{"date":103,"type":43},"2025-12-17",{"date":105,"type":43},"2023-04-03",{"date":107,"type":22},"2029-09-28",{"name":109,"class":110},"VA Office of Research and Development","FED",40,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":51},"100480194","phase-3-evaluation-of-the-efficacy-and-safety-of-metformin-in-the-myotonic-dystrophy-type-1-steinerts-disease-100480194","NCT05532813","Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease)","Evaluation of the Efficacy and Safety of Metformin in the Myotonic Dystrophy Type 1 (Steinert's Disease). A Phase III, Prospective, Multicentre, Randomized, Double-blind Controlled Study","METFORMYO","Inclusion Criteria:\n\n* DM1 disease confirmed by genetic analysis\n* Men and women between 18 and 70 years of age.\n* Preserved walking abilities (stick assistance possible)\n* MIRS score 3 or 4\n* Women of childbearing potential under efficient contraception during treatment\n* Patient able to consent\n* All patients who have completed and signed the specific information and informed consent form\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Men with an intention to conceive a child during the time of the study\n* Contraindications to Metformin (hypersensitivity to metformin or to one of the excipients)\n* Respiratory:\n\n  * Patient requiring tracheotomy or\n  * Patient requiring non-invasive-ventilation: - more than 12 hours per day; - insufficiently ventilated\n* Creatinine clearance inferior to 50 ml\u002Fmin\n* Cardiac:\n\n  * Left ventricular ejection fraction below 35%\n  * Conduction system disease on the electrocardiogram with PR interval \\>200 ms or QRS duration \\>110 ms without a pacemaker or an implantable defibrillator or cardiac electrophysiological study performed over the past 5 years\n  * Third-degree or Second degree type II atrioventricular block without a pacemaker or an implantable defibrillator\n  * Sustained ventricular tachycardia\n* Acute disease that may lead to tissue hypoxia","70 Years",{"count":122,"type":22},142,[124],"PHASE3","The study team hypothesize that non-diabetic patients with Myotonic dystrophy type I (DM1) will improve their symptoms, especially their motor deficit which is the main feature of the disease, because of the splicing defect correction by metformin.\n\nThe primary objective of the study is to evaluate the efficacy of metformin vs placebo, on the improvement of muscle function in patients with DM1 compared to its placebo.\n\nAs the secondary objectives, the study aims:\n\n* To evaluate the safety of metformin on patient with DM1.\n* To evaluate the efficacy of metformin vs placebo on:\n\n  1. The hand-grip strength;\n  2. The thumb-index pinch strength;\n  3. The locomotor function;\n  4. The respiratory function;\n  5. The cardiac function;\n  6. The quality of life;\n  7. The daily and social activity.",[127,128,31],"Steinert's Disease","Myotonic Dystrophy 1",[127,128,31,130],"Muscle function","2025-11-19",{"date":133,"type":43},"2025-11-24",{"date":135,"type":43},"2024-11-29",{"date":137,"type":22},"2026-12",{"name":139,"class":50},"Assistance Publique - Hôpitaux de Paris",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":51},"100607785","clinical-and-biological-signs-of-dapagliflozin-overdose-in-icu-patients-with-metformin-poisoning-100607785","NCT07193069","Clinical and Biological Signs of Dapagliflozin Overdose in ICU Patients With Metformin Poisoning","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Admission to an intensive care unit (ICU) due to acute drug poisoning\n* Documented exposure to either:\n* Metformin alone\n* Metformin in combination with dapagliflozin\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* No exposure to metformin\n* Exposure to dapagliflozin without metformin",{"count":147,"type":22},50,"OBSERVATIONAL","This study looks at patients admitted to intensive care for drug poisoning involving metformin, a common diabetes medication. Researchers will compare two groups: patients who overdosed on metformin alone and those who took both metformin and dapagliflozin, another diabetes drug. The goal is to find clinical or laboratory signs that could help doctors quickly recognize a dapagliflozin overdose in this context, which could improve treatment and patient outcomes.",[151,31,152,153,154,155],"Drug Overdose","Dapagliflozin","Lactic Acidosis","Diabetic Ketoacidosis","Intensive Care Units","2025-09-24",{"date":158,"type":43},"2025-09-25",{"date":160,"type":43},"2025-04-11",{"date":162,"type":22},"2026-04-11",{"name":164,"class":50},"Centre Hospitalier de Saint-Denis",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":23,"phases":173,"briefSummary":175,"conditions":176,"keywords":179,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":188,"locationsCount":51},"100510673","phase-2-phase-2-open-label-single-arm-study-on-the-use-of-metformin-as-adjunctive-therapy-in-high-grade-glioma-100510673","NCT05929495","Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma","Inclusion Criteria:\n\n* Patients with newly diagnosed histologically confirmed GBM (WHO grade IV, IDH wild type) undergoing surgical resection;\n* hypomethylation or hypermethylation of MGMT assessed post-surgery;\n* adult patients (≥18 years), both sexes;\n* Patients undergoing Stupp protocol including patients aged \\> 70 years performing the hypofractionated protocol and three weeks of chemotherapy;\n* Karnofsky Performance Status (KPS)\\> 60 assessed post-surgery;\n* life expectancy at least 6 months defined by size and location of lesion tumor;\n* freely given written informed consent prior to any activity related to the study. Patients must be able to communicate with the investigator and comply with the study procedures;\n* Women of childbearing age must test negative for pregnancy at enrollment and, if they have sexual intercourse, they must agree to use specific contraceptive methods. Female subjects of childbearing age, i.e., fertile, after menarche and until post-menopause unless they are permanently infertile, who are sexually active, must apply a highly effective method of birth control with a low failure rate (i.e., less than 1 percent per year), such as combined hormonal contraception (containing estrogen and progestin) combined with ovulation inhibition (oral intravaginal, or transdermal), progestin-only hormonal contraception associated with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone delivery system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence, throughout the treatment period and for four weeks after the last dose of the study treatment. Hormonal methods other than levonorgestrel-containing devices or medroxyprogesterone injections should be supplemented with the use of a male condom. Women of nonfertile age may be included if surgically sterile or postmenopausal for at least 2 years. The investigator is responsible for determining whether the patient has adopted an appropriate method of contraception for participation in the study.\n* Male subjects with female partners of childbearing age must use condoms during treatment and until the end of relevant systemic exposure.\n\nExclusion Criteria:\n\n* Multicenter GBMs;\n* Patients diagnosed with diabetes or diabetes-related conditions;\n* other active malignancies;\n* hypersensitivity, intolerance to metformin or excipients;\n* Impaired renal function with creatinine clearance \\\u003C 60 mL\u002Fmin assessed at recruitment, liver failure assessed at recruitment by clinical history and examination of ALT, AST and total bilirubin, and other contraindications to metformin use;\n* taking metformin, insulin or other biguanides, regardless of the reason;\n* pregnancy or lactation;\n* patient has serious pre-existing medical conditions that, in the opinion of the investigator, would preclude participation in this study.",{"count":172,"type":22},25,[174],"PHASE2","About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies.\n\nThis is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months.\n\nThe clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.",[177,31,178],"Glioblastoma, IDH-wildtype","Malignancies",[31,180,181],"Gliomas","GBM","2025-07-24",{"date":184,"type":43},"2025-07-25",{"date":186,"type":43},"2024-02-12",{"date":45,"type":22},{"name":189,"class":50},"University of Milano Bicocca",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":198,"sex":199,"minAge":18,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":51},"100551378","phase-2-pilot-study-on-evaluating-the-geroprotective-effect-of-metformin-100551378","NCT06459310","Pilot Study on Evaluating the Geroprotective Effect of Metformin","A Phase II Exploratory Clinical Study Investigating the Geroprotective Effect of Metformin in Middle-aged and Elderly People","AGE-M","Inclusion Criteria：\n\n1. Male\n2. Age 55-65; 18-28;\n3. Able to understand and execute instructions;\n4. After reading the consent form, be able to answer questions about the study and demonstrate understanding of the protocol;\n5. Be able to participate in regular follow-up visits.\n\nExclusion Criteria\n\n1. Severe chronic or acute disease: cancer, clinically significant congestive heart failure, chronic obstructive pulmonary disease (COPD), previous or new-onset diabetes, inflammatory state, serum creatinine \\>1.5 mg\u002Fdl , active liver disease, History of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) cardiovascular events (MI, PTCA, CABG, stroke), severe renal insufficiency, inflammatory bowel disease, persistent glucocorticoids Treatment; neurological diseases such as dementia, AD, PD, etc.; infectious diseases such as HIV, hepatitis, tuberculosis, etc.; severe autoimmune diseases;\n2. BMI\\\u003C18.5 or BMI\\>30;\n3. Persistent alcohol or drug abuse;\n4. Treatment with drugs known to affect glucose metabolism (other diabetes drugs, systemic glucocorticoids, niacin);\n5. Hypersensitivity to metformin or any component of the preparation;\n6. Have taken metformin, low-dose aspirin, acarbose, vitamin C in the recent (3 months);\n7. Unable to provide informed consent;\n8. Other circumstances in which the researcher believes that the physical factors of the participants may adversely affect the research process or results.",true,"MALE","65 Years",{"count":202,"type":22},130,[174],"The objective of this research is to assess the efficacy of oral metformin in mitigating the aging process in middle-aged and elderly males, to pinpoint sensitive indicators of human senescence, and to offer innovative frameworks and scientific insights for pharmaceutical interventions in aging.",[31,206],"Aging",[208,209,210,211,212,213,214],"aging intervention","metformin","aging biomarker","multi-omics","middle-aged and elderly people","molecular clocks","biological age","2025-03-18",{"date":217,"type":43},"2025-03-21",{"date":219,"type":43},"2024-06-30",{"date":221,"type":22},"2028-07-31",{"name":223,"class":50},"Xuanwu Hospital, Beijing",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":51},"100448519","phase-4-metformin-in-children-with-fragile-x-syndrome-100448519","NCT05120505","Metformin in Children With Fragile X Syndrome","Efficacy and Safety of Metformin in the Treatment of Fragile X Syndrome","Inclusion Criteria:\n\n* Genetic testing confirms the diagnosis of FXS\n* Participate in the study with the informed consent of the guardian\n* BMI\\>the 3rd percentile\n* Not taking more than 2 therapeutic drugs\n* Able to receive regular follow-up visits\n\nExclusion Criteria:\n\n* Malnutrition\n* Primary heart disease\n* Severe infection or acute clinical illness\n* Gastrointestinal, renal, or hepatic disease\n* Previous history of lactic acidosis\n* previous use of metformin intolerant\n* Use of angiotensin converting enzyme inhibitors, use of anticoagulants, vitamin B12 deficiency, alcohol consumption\n* Unstable systemic diseases other than FXS\n* Changes in clinical medication","2 Years","16 Years",{"count":234,"type":22},20,[62],"This study is a controlled trial of metformin in children with fragile X syndrome(FXS). The age of FXS children range from 2 to 16 years old. Participants will be randomized in a double-blind design to either drug or placebo for 6-month period. The primary objectives are to assess metformin in treatment of behavior problems, cognitive and language with fragile X syndrome.",[238,31],"Fragile X Syndrome","2025-02-16",{"date":241,"type":43},"2025-02-18",{"date":243,"type":43},"2021-12-29",{"date":245,"type":22},"2025-12-30",{"name":247,"class":50},"Children's Hospital of Fudan University",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":255,"minAge":18,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":269,"locationsCount":51},"100571195","study-of-acupuncture-to-control-weight-and-improve-pregnancy-rates-in-overweightobese-pcos-patients-100571195","NCT06717087","Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight\u002FObese PCOS Patients","A Randomized Controlled Study of Acupuncture to Control Weight and Improve Pregnancy Rates in Overweight\u002FObese Polycystic Ovary Syndrome Patients","Inclusion Criteria:\n\n1. Diagnosis of PCOS according to the 2003 Rotterdam criteria with at least two of the following three symptoms: clinical and\u002For biochemical signs of hyperandrogenism (hirsutism or acne), oligomerism\u002Famenorrhea, and\u002For polycystic ovaries (PCOS). Biochemical hyperandrogenism is defined as total testosterone \\> 2.6 nmol\u002FL or free androgen index \\>7. Hirsutism is defined as an FG score ≥7. Oligomenorrhea is defined as menstrual bleeding \\> 35 days between menstrual periods in the past year, \\\u003C 8 menstrual bleeding. Amenorrhea is \\\u003C 3 cycles per year. PCO is defined by transvaginal ultrasound, where one or both ovaries ≥ 12 follicles 2-9 mm and\u002For ovarian volume ≥ 10 mL. Other endocrine disorders such as atypical congenital adrenal hyperplasia (17-hydroxyprogesterone \\\u003C3 nmol\u002FL), androgen-secreting tumors, or suspected Cushing syndrome are excluded.\n2. Age from ≥ 20 years old (legal age of marriage) to ≤ 40 years old\n3. PCOS patients: BMI ≥ 25 to ≤40kg\u002Fm2.\n4. Willing to sign the consent form.\n\nExclusion Criteria:\n\n1. History of severe heart disease, hematologic disease;\n2. Known kidney disease (creatinine clearance rate \\\u003C45mL\u002Fmin), liver function ALT, AST more than 3 times the normal value, autoimmune disease or cancer;\n3. Any acute disease that has the potential to alter renal function or cause tissue hypoxia;\n4. Type I diabetes mellitus;\n5. Medication within 12 weeks (hormonal drugs, antidepressants, other anti-diabetic drugs, contraceptives, ovulation induction drugs or other drugs that affect the trial in the judgment of the investigator);\n6. Allergy to metformin hydrochloride or any excipients;\n7. Blood pressure \\> 160\u002F100 mm Hg;\n8. Pregnancy or breastfeeding in the past three months;\n9. No history of acupuncture treatment within 2 months;\n10. Alcohol dependence\n11. Persons with disabilities with language impairment or reduced ability to understand the information provided;\n12. Those who have participated in other clinical studies within three months;\n13. The man clearly diagnoses infertility-related diseases and factors.","FEMALE","40 Years",{"count":258,"type":22},92,[25],"Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility and is characterized by ovulatory dysfunction, increased androgens, and polycystic ovaries. The goal of this randomized control study is to compare the efficacy between acupuncture and metformin both with intensive lifestyle intervention for overweight \u002Fobese PCOS patients in weight and pregnancy rates improvement.",[262,31,263],"Polycystic Ovary Syndrome","Acupuncture",{"date":265,"type":43},"2024-12-04",{"date":267,"type":22},"2024-12-20",{"date":78,"type":22},{"name":270,"class":50},"RenJi Hospital",{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":198,"sex":255,"minAge":279,"maxAge":256,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":51},"100521059","effect-of-metformin-on-healthy-live-birth-in-women-with-prediabetes-100521059","NCT06064669","Effect of Metformin on Healthy Live Birth in Women With Prediabetes","Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial","MELT-PreDM","Inclusion Criteria:\n\n1. Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.\n2. Women aged 20-40 years.\n3. Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.\n\nExclusion Criteria:\n\n1. Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol\u002FL, 2-h plasma glucose during 75-g OGTT ≥11.1mmol\u002FL, HbA1c≥6.5%, or a random plasma glucose≥11.1mmol\u002FL.\n2. Women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, GLP-1 receptor agonist, etc.), weight loss drugs (i.e.orlistat, etc.), glucocorticoids, and growth hormones within 2 months before enrollment.\n3. Women with un-corrected hyperthyroidism or hypothyroidism.\n4. Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.\n5. Women with a diagnosis of adenomyosis.\n6. Women with untreated hydrosalpinx.\n7. Women who plan to undergo PGT-SR or PGT-M.\n8. Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.","20 Years",{"count":281,"type":22},988,[25],"To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.",[31,32,285],"In-Vitro Fertilization","2024-05-27",{"date":288,"type":43},"2024-05-29",{"date":290,"type":43},"2024-02-22",{"date":292,"type":22},"2027-12-31",{"name":294,"class":50},"Shandong University",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":255,"minAge":18,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":51},"100541138","pcos-immune-function-predicts-metformin-efficacy-100541138","NCT06325956","PCOS Immune Function Predicts Metformin Efficacy","Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome","Inclusion Criteria:\n\n* aged 18-45 years\n* Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)\n\nExclusion Criteria:\n\n* Pregnant women;\n* Hyperthyroidism or hypothyroidism\n* Severe liver and kidney function injury\n* Cancer patients;\n* Associated with severe infection, severe anemia, neutropenia and other blood system diseases;\n* Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;\n* Patients with mental illness or intellectual disability;\n* Have taken drugs for PCOS treatment in the last three months;\n* Have a long history of taking hormone therapy;\n* Currently or recently participating in another clinical trial.","45 Years",{"count":304,"type":22},100,[25],"In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.",[262,31,308],"Immune Function","2024-03-21",{"date":311,"type":43},"2024-03-22",{"date":313,"type":43},"2024-03-16",{"date":315,"type":22},"2026-07-01",{"name":317,"class":50},"Shanghai 10th People's Hospital",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":328,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},"100407132","phase-3-extending-time-without-diabetes-after-bariatric-surgery-a-trial-comparing-the-metformin-addition-or-not-to-standard-care-100407132","NCT04581447","Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care","Extending Time Without Diabetes After Bariatric Surgery: a Randomized Controlled Trial Comparing the Metformin Addition or Not to Standard Care","DiabOUT","Inclusion Criteria:\n\n* Adults 18-70 years old\n* Having undergone gastric bypass or sleeve gastrectomy 12 to 36 +\u002F-3 months before inclusion\n* \"ex-T2D\" treated with at least one anti-diabetic drug before bariatric surgery or HbA1c ≥ 6.5 % before bariatric surgery\n* HbA1C \\\u003C 6.5 % at inclusion with no anti-hyperglycemic medications for the last three months\n* Written consent\n\nExclusion Criteria:\n\n* Known type 1 diabetes\n* Pregnancy and breastfeeding\n* Estimated glomerular filtration rate\\\u003C44 ml\u002Fmin (MDRD)\n* Known intolerance to metformin\n* Known contraindication to metformin:\n\n  * Acute metabolic acidosis\n  * Acute affection which could lead to renal deterioration (ex: dehydration, serious infection, shock, intravascular administration of iodinated contrast agent within the last 48 hours)\n  * Acute or chronic disease which could lead to a tissue hypoxia (ex : severe cardiac insufficiency, severe respiratory insufficiency, myocardial infarction within the last 3 months, shock)\n  * Hepatocellular insufficiency\n  * Prothrombin ratio ≤ 50%\n  * SGOT or SGPT levels ≥ 10 times the upper limits of the normal range\n  * Alcohol use disorder\n* Medications and medical conditions likely to confound the assessment of diabetes:\n\n  * glucocorticoids treatment\n  * renal graft\n  * Cushing's syndrome\n  * acromegaly\n  * fasting plasma triglyceride \\> 600 mg\u002Fdl despite treatment\n* Patient under legal protection",{"count":327,"type":22},126,[124],"This study is a randomized trial that evaluates the effect of metformin addition or not to standard care on the duration of diabetes remission after bariatric surgery.",[331,332,31],"Diabetes","Bariatric Surgery",[331,332,334,335,31],"Sleeve gastrectomy","Gastric bypass","2023-06-07",{"date":338,"type":43},"2023-06-08",{"date":340,"type":43},"2021-01-07",{"date":342,"type":22},"2026-11",{"name":139,"class":50},16,{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":279,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":51},"100475340","phase-2-effect-of-tofogliflozin-on-uacr-compared-to-metformin-hydrochloride-in-diabetic-kidney-disease-truth-dkd-100475340","NCT05469659","Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)","Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease","TRUTH-DKD","Inclusion Criteria:\n\n* Type 2 diabetic patients\n* Patients aged 20 years or older at the time of obtaining consent\n* Patients with HbA1c 6.5 or more and 9.0% or less within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor \u002F metformin)\n* Patients who have been judged by their doctor to need a diabetic drug when they are first seen, or who have already taken a diabetic drug and have decided that it is necessary to add one diabetic drug.\n* Patients who have been receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer\n* Patients with eGFR of 30 or more (mL \u002F min \u002F 1.73m2) within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor \u002F metformin)\n* Patients with urinary albumin \u002F creatinine ratio (UACR) of 30 or more and less than 2000 (mg \u002F gCr) (4 weeks or more without taking SGLT2 inhibitor \u002F metformin) within 13 weeks before obtaining consent Evaluate by inspection value)\n* Patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study\n\nExclusion Criteria:\n\n* Patients receiving treatment with SGLT2 inhibitor or metformin within 13 weeks before obtaining consent\n* Dialysis patient\n* Patients with a history of severe hypoglycemia\n* Patients with hypersensitivity to SGLT2 inhibitor or metformin\n* Pregnant women, lactating patients, and patients who wish to raise children\n* Patients with BMI of 35 kg \u002F m2 or more based on the latest measured values within 13 weeks before obtaining consent\n* Patients who are contraindicated for the study drug\n* Other patients who the attending physician deems inappropriate as a subject",{"count":354,"type":22},120,[174],"This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).",[358,31,359],"T2DM (Type 2 Diabetes Mellitus)","SGLT2-Inhibitors","2022-07-21",{"date":362,"type":43},"2022-07-22",{"date":364,"type":43},"2021-09-22",{"date":366,"type":22},"2026-10-30",{"name":368,"class":50},"Shinshu University"]