[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Asger Lund, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":77},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100611988","phase-2-the-effect-of-colchicine-on-insulin-sensitivity-in-individuals-with-type-1-diabetes-and-systemic-low-grade-inflammation-100611988",false,"NCT07247734","The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation","The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation: A Randomized, Double-Blind, Placebo-Controlled, Investigator-Initiated Trial","INS1GHT","Inclusion Criteria:\n\n* Type 1 diabetes for more than five years according to World Health Organization criteria and c-peptid \\\u003C200 pmol\u002FL\n* Age 18-80 years\n* User of a continuous glucose monitor (CGM) system\n* Glycated hemoglobin A1c (HbA1c) 42-75 mmol\u002Fmol\n* Stable insulin therapy (defined as no change in insulin brand and no newly initiated Continuous subcutaneous insulin infusion (CSII) or Multiple dose injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continuous glucose monitor or intermittently scanned continuous glucose monitor) ≥ 3 months with either multiple daily injections or continuous subcutaneous insulin infusion\n* Estimated glomerular filtration rate ≥ 60 mL\u002Fmin\u002FL\u002F1.73 m²\n* Estimated glucose disposal rate (eGDR)\\* \\\u003C 8 mg\u002Fkg\u002Fmin OR insulin usage of ≥1 IU\u002Fkg pr day\n* C-reactive protein (CRP) hsCRP ≥ 2 mg\u002FL, (measured by high-sensitivity assay)\\*\\*\n\nExclusion Criteria:\n\n* Hypoglycaemia unawareness (inability to register low blood glucose) ad modum Pedersen-Bjergaard, 24 unless the individual uses a continuous glucose monitor with alarm function\n* Liver disease with elevated plasma alanine aminotransferase (ALT) \\> three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within seven days, and the last measured value as being conclusive)\n* History of cirrhosis, chronic active hepatitis, or severe hepatic disease\n* Inflammatory bowel disease or chronic diarrhoea\n* Pre-existing progressive neuromuscular disease or individuals with creatinine kinase levels \\> three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)\n* Cancer or lymphoproliferative disease unless in complete remission for \\> 5 years\n* Blood dyscrasias (e.g., myelodysplastic syndromes or related haematological disorders)\n* Leukocyte cell count \\\u003C 3.0 X 109\u002FL\n* Thrombocyte count \\\u003C 110 X 109\u002FL\n* Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV)\n* Treatment with anti-inflammatory drugs (e.g., non-steroidal anti-inflammatory drugs (NSAID), acetylsalicylic acid (ASA), prednisone) or whole-body topical steroid during the study or within four weeks before study start. Inhaled steroids are allowed. Short term oral NSAID treatment (≤ 3 days) within four weeks before study start or during the study period is allowed. Treatment of ASA is allowed for up to 1000 mg daily.\n* Treatment with colchicine within 60 days of screening visit\n* Known or suspected hypersensitivity to colchicine\n* Treatment with glucose lowering drugs other than insulin (e.g., Glucagon Like Peptide 1 (GLP-1) receptor agonists, metformin, selective sodium glucose cotransporter-2 (SGLT2)-inhibitors) during the study period or within four weeks before study start\n* Haemodialysis or peritoneal dialysis therapy (since colchicine cannot be removed by dialysis or exchange transfusion)\n* Treatment with a P-glycoprotein inhibitor (e.g., azithromycin and verapamil) or a strong CYP3A4 inhibitor (e.g., clarithromycin and ritonavir)\n* Intake of grapefruit juice\n* Other concomitant disease or treatment that according to the investigator's assessment makes the individual unsuitable for study participation\n* Alcohol\u002Fdrug abuse (assessed by the investigator)\n* Regarding fertile women:\n\n  * A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n  * Sterilised or postmenopausal women (no menses for 12 months without an alternative medical cause) can be included without the human chorionic gonadotrophin (hCG)-testing during the trial period\n  * Women who are pregnant, intend to become pregnant, or are breastfeeding will not be included in the study\n  * Female of childbearing potential: must use highly effective contraceptives during the trial and three months after the trial. To exclude pregnancy, urine hCG tests are performed in relation to all visits (V1-V5) and to the phone call in the washout period (P2) and there will be instructions to ensure monthly testing three months after the end of the trial.\n  * The following contraceptive methods are considered highly effective and thus adequate for study enrolment for females if maintained throughout the study duration and three months after the trial: Combined hormonal contraception associated with inhibition of ovulation (containing estrogen and progestogen administered oral, intravaginal or transdermal). Progestogen-only hormonal contraception associated with inhibition of ovulation (admninistered oral, injectable or implantable). Intrauterine device (IUD). Intrauterine hormone-releasing system. Bilateral tubal occlusion. Vasectomised partner. Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).\n  * Male participants with partners of childbearing potential: must either use a condom or ensure that their partner uses a highly effective contraceptive method during the trial and six months after the trial.\n* Pregnant or nursing women\n* Participants unable to speak or understand Danish\n* Receipt of any investigational drug within 30 days prior to visit 1\n* Simultaneous participation in any other clinical intervention trial","ALL","18 Years","80 Years",{"count":21,"type":22},26,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.",[28,29,30],"Type 1 Diabetes","Chronic Inflammation","Insulin Sensitivity","RECRUITING","2025-12-22",{"date":34,"type":35},"2025-12-23","ACTUAL",{"date":37,"type":35},"2025-12-01",{"date":39,"type":22},"2027-06-22",{"name":41,"class":42},"Asger Lund, MD","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":43},"100596185","phase-4-treatment-of-bile-acid-diarrhoea-with-atorvastatin-100596185","NCT07042165","Treatment of Bile Acid Diarrhoea With Atorvastatin","Treatment of Bile Acid Diarrhoea With Atorvastatin (BASTA): A Randomised, Double-Blind, Placebo-Controlled, Crossover, Investigator-Initiated Trial","BASTA","Inclusion Criteria:\n\n* age 18 years or above\n* Self-identification as White\n* Confirmed moderate-severe bile acid diarrhoea with a SeHCAT test result of ≤ 10 %\n* Reported number of average daily stools ≥ 3 stools per day\n* Reported number of average daily watery (6 or 7 on the Bristol Stool Chart) stools ≥ 1 stools per day(30)\n* Informed and written consent\n\nExclusion Criteria:\n\n* Unwillingness to pause any of the following medications during the trial: bile acid sequestrants, morphine medication, liraglutide or anti-constipation medication (e.g., lactulose, laxoberal, magnesia)\n* Unwillingness to pause any anti-diarrhoea medication (e.g., imodium) from 3 days before initiation of each stool diary until after the respective visit\n* If regularly administering psyllium or metformin, unwillingness to agree to a stable dose of psyllium or metformin throughout the trial\n* Concomitant use of any drug in the GLP-1 receptor agonist drug class with the exception of paused liraglutide, see above\n* Concomitant use of any kind of insulin medication\n* Planned major changes in food consumption throughout the trial, including planned weight loss attempts\n* Prior use of any statin within the recent 6 months\n* Intake of larger quantities of grapefruit juice during trial participation, at the discretion of the investigator\n* History of\u002Fpresent hepatobiliary disorder (except for simple metabolic dysfunction-associated fatty liver disease) and\u002For alanine aminotransferase and\u002For serum aspartate aminotransferase ≥ 3 times upper limit of normal\n* Crohn's disease, ulcerative colitis, celiac disease or lactose intolerance\n* Previous intestinal resection or major intra-abdominal surgery incl. stoma (cholecystectomy and appendectomy not included)\n* Nephropathy with estimated glomerular filtration rate \\\u003C 45 ml\u002Fmin\u002F1,73 m2\n* Plasma level of creatine kinase ≥ 5 times the upper limit of normal\n* A recent stroke or transient ischemic attack (within 6 months)\n* Any treatment or condition requiring acute or subacute medical or surgical intervention\n* Hypothyroidism or hyperthyroidism, if not well regulated, at the discretion of the investigator\n* Active or recent (within 6 months) clinically significant malignant disease (non-melanoma skin cancer not included), at the discretion of the investigator\n* Alcohol consumption exceeding 12 units\u002Fweek for women or 18 units\u002Fweek for men, respectively. These thresholds are based on the limits of the European Association for the Study of the Liver\n* Drug abuse, at the discretion of the investigator\n* Fertile women not using any of the following contraceptive methods for the duration of the trial until at least 5 days after end of trial: Hormonal (tablet\u002Fpill, depot injection of progesterone, subdermal gestagen implantation, hormone intrauterine devices (IUD), hormonal vaginal ring or transdermal hormonal patch) associated with inhibition of ovulation, chemical (copper IUD), sterilisation, vasectomised partner with a confirmatory test, or sexual abstinence per the investigator's discretion\n* Pregnant or nursing women\n* Known or suspected hypersensitivity to atorvastatin or any of the additives in the tablet\n* Receipt of any investigational drug within 30 days prior to visit 0\n* Concomitant treatment with any of the following (topical administration not included): ciclosporin, telithromycin, clarithromycin, delavirdin, stiripentol, ketoconazol, voriconazol, itraconazol, posaconazol, letermovir, ritonavir, lopinavir, atazanavir, indinavir, darunavir, bocepravir, telaprevir, elbasvir\u002Fgrazoprevir, ledipasvir\u002Fsofosbuvir, erythromycin, niacin, ezetimibe, fusidic acid, gemfibrozil, colchicine, digoxin, warfarin\n* Unable to speak or understand Danish or mental incapacity that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements\n* Active participation in any other clinical intervention trial (observational studies not included)\n* Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation",{"count":53,"type":22},20,[55],"PHASE4","Bile acid diarrhoea (BAD) is a socially debilitating disease with stomach pain, high stool frequency, urgency, and faecal incontinence as the main symptoms. Studies estimate that 1-2% of the population suffers from the disease.\n\nThere is an unmet need for more treatment options in patients suffering from BAD.\n\nThe investigators hypothesise that atorvastatin treatment lowers bile acid synthesis in patients with bile acid diarrhoea. The investigators will investigate this hypothesis in the current study, BASTA, which is a Randomised, Double-Blind, Placebo-Controlled, Crossover, Proof of Concept, Investigator-Initiated, Trial.",[58,59],"Bile Acid Diarrhea","Bile Acid Malabsorption",[58,59,61,62,63,64,65,66,67,68],"Atorvastatin","Randomised","Placebo","7-alpha-C4","Crossover","Double-blind","Investigator-initiated","Proof of concept","2025-11-24",{"date":71,"type":35},"2025-12-02",{"date":73,"type":35},"2025-10-15",{"date":75,"type":22},"2026-12",{"name":41,"class":42},""]