[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"severe-obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:severe-obesity":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,86,110,137],{"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":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100597412","phase-4-optimizing-portal-hypertension-with-tips-and-interval-metabolic-surgery-for-advanced-liver-disease-100597412",false,"NCT07058155","Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease","OPTIMAL Trial: Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease","OPTIMAL","Inclusion Criteria\n\n1. Candidate for general anesthesia.\n2. Age 18-70 years at consent.\n3. BMI 35-70 kg\u002Fm² at first study visit.\n4. Eligible for sleeve gastrectomy per ASMBS\u002FIFSO 2022 guidelines.\n5. Insurance coverage for metabolic surgery.\n6. Current or prior anti-obesity medication use permitted.\n7. Liver cirrhosis confirmed by biopsy or non-invasive assessment.\n8. Clinically significant portal hypertension (HVPG ≥ 10 mm Hg, or esophagogastric varices \u002F portal-hypertensive gastropathy, or imaging evidence of collaterals\u002Fdilated portal vein).\n9. Able and willing to provide informed consent and comply with study procedures.\n10. Women of child-bearing potential: negative urine pregnancy test at screening and randomization and agreement to reliable contraception for 2 years.\n\nExclusion Criteria\n\n1. Prior bariatric\u002Fmetabolic surgery (except removed devices ≥ 3 months earlier).\n2. Prior complex foregut surgery.\n3. History of solid-organ transplant.\n4. Severe pulmonary disease (FEV1 \\\u003C 50 % predicted).\n5. Significant cardiac or atherosclerotic disease with planned re-vascularization within 12 months.\n6. ASA class IV or V uncompensated cardiopulmonary disease.\n7. Left-ventricular ejection fraction \\\u003C 25 % or MI\u002Funstable angina\u002Fstroke\u002Fheart surgery\u002Fcoronary stent within 6 months.\n8. Hiatal hernia \\> 7 cm or LA grade C\u002FD erosive esophagitis.\n9. Active Crohn's disease.\n10. Severe psychiatric illness, dementia, active psychosis, history of suicide attempt, or alcohol\u002Fsubstance abuse within 12 months.\n11. Pregnant, breastfeeding, planning pregnancy, or not using adequate contraception.\n12. Malignancy within the prior 12 months (except non-melanoma skin cancer).\n13. Life expectancy \\\u003C 2 years in investigator's judgment.\n14. Investigational therapy within 3 months.\n15. Acute pancreatitis ≤ 90 days.\n16. Portal vein thrombosis at screening.\n17. Decompensated cirrhosis (moderate\u002Flarge ascites, hepatic encephalopathy, or listed for liver transplant); small ascites or prior variceal bleed allowed.\n18. Total bilirubin \\> 3 mg\u002FdL, INR \\> 1.7, or platelets \\\u003C 50 000\u002FµL (within 1 month).\n19. Significant alcohol intake (\\> 14 units\u002Fweek women, \\> 21 units\u002Fweek men) within the prior 12 months.\n20. eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m² or on dialysis (within 1 month).\n21. AIDS.\n22. Unable to understand study or give consent.\n23. Plans to move more than 3 hours from Cleveland within 6 months.\n24. Previous randomization in this trial.\n25. Any condition that, in the investigator's opinion, places the subject at undue risk.","ALL","18 Years","70 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. CSPH raises the risk of life-threatening events like internal bleeding and liver failure. Unfortunately, treatment options for people who have both cirrhosis and severe obesity are very limited, especially when portal hypertension is present.\n\nThis study, called the OPTIMAL Trial, is a randomized clinical trial designed to evaluate whether combining two procedures improves health outcomes in this high-risk population. The first procedure, called TIPS (Transjugular Intrahepatic Portosystemic Shunt), is a minimally invasive treatment that reduces pressure in the liver by creating a pathway for blood to flow more easily. The second procedure is sleeve gastrectomy, a form of metabolic (bariatric) surgery that helps patients lose weight and improve related conditions like diabetes.\n\nThe study will compare two groups:\n\n1. One group will receive TIPS followed by sleeve gastrectomy (TIPS+SG).\n2. The other group will receive medical weight management (standard non-surgical care, including diet, lifestyle changes, and weight loss medications).\n\nAll participants will have severe obesity and cirrhosis with CSPH but will not have decompensated liver disease (such as large amounts of fluid in the abdomen, a history of variceal bleeding, or recent liver failure). Eligible participants will be randomly assigned to one of the two groups.\n\nThe main goal of the study is to determine whether the combination of TIPS + SG improves quality of life and leads to greater weight loss compared to medical therapy alone. The study will also monitor for any complications from either the procedures or the medical treatment.\n\nParticipants will be followed for 6 months after their treatment starts, with periodic assessments of their physical health, liver function, and overall well-being. Some participants may also be followed for a longer period to assess long-term outcomes.\n\nThis study hopes to provide high-quality evidence for a novel, stepwise treatment strategy that may help people with obesity and liver disease live longer, healthier lives. If successful, it could change how advanced liver disease and obesity are managed together, especially in patients who currently have few safe and effective options. All study care is provided at Cleveland Clinic, Cleveland, Ohio, USA.",[28,29,30,31],"Liver Cirrhoses","Portal Hypertension Related to Cirrhosis","Severe Obesity","TIPS",[33,34,35,36,37,38,39,40,41,42],"Sleeve Gastrectomy","Transjugular Intrahepatic Portosystemic Shunt (TIPS)","Bariatric Surgery \u002F Metabolic Surgery","Clinically Significant Portal Hypertension (CSPH)","Health-Related Quality of Life (HRQOL)","SF-36 Questionnaire","Weight Loss","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Randomized Controlled Trial","RECRUITING","2025-12-20",{"date":46,"type":47},"2025-12-23","ACTUAL",{"date":49,"type":47},"2025-12-17",{"date":51,"type":22},"2034-02-01",{"name":53,"class":54},"The Cleveland Clinic","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":55},"100605091","comparison-of-nissen-sleeve-and-gastric-bypass-for-gerd-in-obese-patients-100605091","NCT07158008","Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients","The SLEEVE-GERD Trial: A Comparative Study of Nissen-Sleeve and Roux-en-Y Gastric Bypass in Obese Patients With GERD","SLEEVE-GERD","Inclusion Criteria:\n\nFor N-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms:\n\n* Age ≥ 18 years\n* Written informed consent provided\n* Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg\u002Fm² or BMI ≥ 35 kg\u002Fm² with obesity-related comorbidities)\n* Presence of symptomatic gastroesophageal reflux disease (GERD), defined by at least one of the following:\n* Regular use of proton pump inhibitors (PPIs)\n* GerdQ score \\> 6\n* Endoscopic evidence of esophagitis (Los Angeles classification grade B or higher)\n\nFor Sleeve Gastrectomy (SG) observational control group:\n\n* Age ≥ 18 years\n* Written informed consent provided\n* Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg\u002Fm² or BMI ≥ 35 kg\u002Fm² with obesity-related comorbidities)\n* No symptoms or history of GERD\n\nExclusion Criteria:\n\n* History of prior anti-reflux surgery\n* History of upper gastrointestinal tract surgery\n* Active smoking or history of nicotine use\n* Severe cardiac insufficiency (New York Heart Association Class III or IV)\n* Pregnancy or planned pregnancy during the study period (if applicable based on future additions)\n* Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with the study protocol or would pose additional risk","65 Years",{"count":66,"type":22},560,[68],"NA","This randomized clinical trial aims to compare two surgical techniques for the treatment of obesity in patients who also have symptoms of gastroesophageal reflux disease (GERD). The study will compare Nissen-Sleeve Gastrectomy (N-SG)-a sleeve gastrectomy combined with a reflux-preventing procedure-to the Roux-en-Y Gastric Bypass (RYGB), which is the current standard surgical option for obese patients with GERD.\n\nBoth procedures are widely used to treat severe obesity, but they differ in how they affect the digestive system and the potential for reflux control, nutritional outcomes, and future surgical options. N-SG is a newer technique that preserves the natural pathway of the gastrointestinal tract and allows standard endoscopic access to the bile ducts, which may be beneficial for long-term patient care. RYGB, on the other hand, bypasses part of the stomach and small intestine, which may lead to better reflux resolution but carries risks of nutritional deficiencies and altered anatomy.\n\nEligible participants with obesity and GERD symptoms will be randomly assigned to receive either N-SG or RYGB. The primary goal is to evaluate whether N-SG is not inferior to RYGB in reducing GERD symptoms one year after surgery. Secondary outcomes include weight loss, quality of life, surgical complications, and changes in the hormone ghrelin, which is involved in appetite regulation.\n\nIn addition, a larger control group of patients without GERD undergoing standard sleeve gastrectomy will be recruited to allow further comparisons. All participants will be followed for one year after surgery, with blood samples, questionnaires, and clinical data collected to assess both metabolic and reflux-related outcomes.\n\nThis study is being conducted at the University Hospital in Kraków, Poland, and aims to improve the personalization of bariatric treatment for patients suffering from both obesity and reflux.",[71,30,72],"Gastro Esophageal Reflux","Bariatric Surgery",[74,75,76],"Nissen-Sleeve","Gastric Bypass","GERD","2025-08-28",{"date":79,"type":47},"2025-09-05",{"date":81,"type":47},"2025-07-31",{"date":83,"type":22},"2028-09",{"name":85,"class":54},"Jagiellonian University",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":94,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100603332","mazdutide-as-adjuvant-therapy-following-sleeve-gastrectomy-in-severe-obesity-100603332","NCT07135141","Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity","Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity:A Multicenter, Randomized, Double-Blind, Placebo-Controlled Superiority Trial","SMART","Inclusion Criteria:\n\n* Aged 18-70 years (inclusive), male or female;\n* BMI≥37.5 kg\u002Fm2, with or without obesity-related complications;\n* Planned to take sleeve gastrectomy\n* Understand the trial protocol, voluntarily sign the informed consent form (ICF), and agree to follow all study requirements and restrictions.\n\nExclusion Criteria:\n\n* Previous gastrointestinal surgery such as stomach and duodenum, or weight loss and metabolic surgery;\n* History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B, or relevant family history;\n* ALT \\> 3.0 × ULN (if NAFLD is diagnosed at screening and within 6 months prior to screening, ALT ≤ 5.0 × ULN can be enrolled), or AST \\> 3.0 ×ULN, or total bilirubin (TBIL) \\> 2 × ULN\n* Estimated glomerular filtration rate eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 using the CKD-EPI equation\n* Chronic anemia：Hemoglobin \\\u003C 110 g\u002FL (males) or \\\u003C 100 g\u002FL (females)；\n* Have the following 12-lead electrocardiogram (ECGs) abnormalities at screening(\\\u003C50 beats\u002Fmin or \\>100 beats\u002Fmin), 2nd or 3rd degree atrioventricular block, long QT syndrome or QTcF \\> 450 ms (males), QTcF \\> 470 ms (females), left or right bundle branch block, pre-excitation syndrome, or other significant arrhythmia (except sinus arrhythmia);\n* Acute hyperglycemic\u002Fhypoglycemic events within 1 year, including:\n\ndiabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), and hypoglycemic coma, etc;\n\n* Participants with previous severe myocardial infarction, stroke, acute and chronic heart failure, cardiac procedure such as percutaneous coronary intervention, coronary artery bypass grafting, or are not suitable for participation in this study after the investigator's assessment;\n* Previous or confirmed mental illness at screening\u002Frandomization phase\\[Previous moderate to severe depressionPHQ questionnaire (Depression Screening Scale) ≥ 15 points, C-SSRS questionnaire (Columbia Suicide Severity Scale) category 4 or 5 at screening or randomization, or \"Yes\" in suicidal behavior or suicidal ideation\\];\n* Previous specific infectious diseases, incl. acquired immunodeficiency syndrome, viral hepatitis B, viral hepatitis C, etc;\n* End-stage disease with an expected survival of less than 5 years or previous\u002Fcurrent malignancy;\n* Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R\u002FGCGR agonists or GIPR\u002FGLP-1R agonists or GIPR\u002FGLP-1R\u002FGCGR agonists within three months prior to screening;\n* History of alcohol or drug abuse at screening;\n* History of specific drugs use beyond 2 times, incl. moderate anticholinergics, antiparkinsonians, antiepileptic drugs, antipsychotics, benzodiazepines and sedatives, morphine and narcotic analgesics, stimulant drugs, medical marijuana, marijuana, and cannabidiol, etc.;\n* Pregnant or lactating females, males or females of childbearing potential who are not willing to use contraception throughout the study and for 8 weeks after the end of the study;\n* Having participated in other clinical investigators who have a conflict of interest with this study;\n* The investigator suspects that the participant may be allergic to ingredients in the study drug or drugs of the same class;",{"count":95,"type":22},256,[68],"The SMART study is a 96-week, multicenter, randomized, double-blind, placebo-controlled superiority clinical trial. A total of 256 severe obesity patients are randomized 1:1 to either receive the bariatric surgery plus GCG\u002FGLP-1 dual receptor agonist group (receiving sleeve gastrectomy followed by subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the bariatric surgery plus placebo group (receiving matched procedure plus placebo injections). The primary objective is to evaluate the potential enhancing weight reduction effects of the combination therapy with bariatric surgery and mazdutide measured by the percentage change of excess weight loss.",[30],"NOT_YET_RECRUITING","2025-08-20",{"date":102,"type":47},"2025-08-21",{"date":104,"type":22},"2025-09-30",{"date":106,"type":22},"2029-09-30",{"name":108,"class":54},"Beijing Friendship Hospital",14,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":119,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":55},"100558161","bone-and-muscle-health-following-sleeve-gastrectomy-in-men-premenopausal-and-postmenopausal-women-100558161","NCT06547515","Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women","BONUS","Inclusion Criteria:\n\n* Men and women aged \\>18 years;\n* Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group.\n* Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) \\>40 UI\u002FL.\n* Women taking oral contraceptive pills or hormone replacement therapy\n* Patients with type 2 diabetes.\n\nExclusion Criteria:\n\n* Type 1 diabetes;\n* Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)\n* Metabolic bone disease other than osteoporosis or type 2 diabetes,\n* Creatinine clearance \\\u003C30 ml\u002Fmin) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;\n* Weight \\>204 kg (DXA weight limit) or BMI \\>60 kg\u002Fm2 (upper limit to allow for QCT examination);\n* Current or planned pregnancy during follow-up; breast-feeding.",{"count":118,"type":22},156,"36 Months","OBSERVATIONAL","Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.",[72,123,30,124],"Bone Health","Muscle Health",[126,127,30,124],"bariatric surgery","Bone health","2025-06-05",{"date":130,"type":47},"2025-06-10",{"date":132,"type":47},"2022-09-14",{"date":134,"type":22},"2026-08-15",{"name":136,"class":54},"CHU de Quebec-Universite Laval",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":143,"maxAge":64,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100574285","endoscopic-conversion-of-sleeve-gastrectomy-to-single-anastomosis-sleeve-ileal-bypass-sasi-for-gastroesophageal-reflux-gerd-primary-and-secondary-non-responder-100574285","NCT06757296","Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.","Inclusion Criteria:\n\nSubject must meet all the inclusion criteria to participate in this study and list each criterion.\n\n1. Age: 21-65 years\n2. Patients going for LSG at participating hospitals.\n3. Able to provide informed consent\n\nIndividuals below age 21 would not be recruited as this is a study in the adult population. Individuals above age 65 are excluded to minimize the procedure risk.\n\nExclusion Criteria:\n\n1. Patients who were breast feeding or pregnant\n2. Severe psychiatric illness\n3. Eating disorder\n4. Active neoplastic disease\n5. End-stage renal disease\n6. Patients with bleeding diathesis\n7. Patients with pacemakers or implantable cardiac defibrillators\n8. Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)\n9. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members)\n10. Treatment with anti-platelet agents that could not be temporarily discontinued","21 Years",{"count":145,"type":22},500,[68],"The aim of this study is to determine the feasibility and effectiveness of endoscopic anastomosis of sleeve gastrectomy to ileum with a lumen apposing metal stent (LAMS) after a failed sleeve gastrectomy.",[149,30,150,72],"Metabolic Syndrome","Reflux, Gastroesophageal",[152,30,72],"SASI","2025-02-13",{"date":155,"type":47},"2025-02-14",{"date":157,"type":47},"2025-02-03",{"date":159,"type":22},"2026-12-31",{"name":161,"class":54},"Singapore Health Services",3]