[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659882":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":66,"studyPopulation":66,"armGroups":73,"interventions":86,"overallOfficials":94,"centralContacts":98,"locations":103,"responsibleParty":122,"collaborators":66,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":66,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":106,"whyStopped":66,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Hospitales Universitarios Virgen del Rocío","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Glycemic Variability Assessed by Glucose Coefficient of Variation","Glycemic variability will be assessed using the glucose coefficient of variation (CV), calculated from 7 days of continuous glucose monitoring as the standard deviation of glucose divided by mean glucose concentration × 100. CV will be assessed at baseline, 6 months, and 12 months after surgery and compared between the SASI and Roux-en-Y gastric bypass groups.","Baseline, 6 months, and 12 months after surgery",[14,17,21,24,27,30,34,37,40,43,47,51,54,57,60,63],{"measure":15,"description":16,"timeFrame":12},"Hypoglycemic Events Detected by Continuous Glucose Monitoring","Number and frequency of symptomatic and asymptomatic hypoglycemic events detected during 7 days of continuous glucose monitoring. Symptomatic events will also be recorded using the participant event diary.",{"measure":18,"description":19,"timeFrame":20},"Body Mass Index","Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg\u002Fm²).","Baseline, 3 months, 6 months and 12 months after surgery",{"measure":22,"description":23,"timeFrame":12},"Patient-Reported Outcomes Assessed by BODY-Q","Patient-reported outcomes related to quality of life and body image will be assessed using the BODY-Q questionnaire.",{"measure":25,"description":26,"timeFrame":12},"Gastroesophageal Reflux Symptoms Assessed by GERD-Q","Gastroesophageal reflux symptoms will be assessed using the GERD-Q questionnaire.",{"measure":28,"description":29,"timeFrame":12},"Eating Behavior Assessed by TFEQ-R18","Eating behavior will be assessed using the Three-Factor Eating Questionnaire-Revised 18-item version (TFEQ-R18).",{"measure":31,"description":32,"timeFrame":33},"Change in Type 2 Diabetes Mellitus Status","Changes in type 2 diabetes mellitus will be assessed using glycated hemoglobin (HbA1c) levels and changes in the requirement for insulin or oral glucose-lowering medications.","Baseline, 3 months, 6 months, and 12 months after surgery",{"measure":35,"description":36,"timeFrame":33},"Change in Hypertension Status","Changes in hypertension will be assessed based on blood pressure measurements and changes in antihypertensive medication requirements.",{"measure":38,"description":39,"timeFrame":33},"Change in Dyslipidemia Status","Changes in dyslipidemia will be assessed based on serum lipid profile, including cholesterol and triglyceride levels, and changes in lipid-lowering medication requirements.",{"measure":41,"description":42,"timeFrame":33},"Nutritional Deficiencies","Nutritional status will be assessed using serum levels of iron, calcium, vitamin D, and vitamin B12.",{"measure":44,"description":45,"timeFrame":46},"Postoperative Complications","Incidence of postoperative complications, including gastroesophageal reflux, anastomotic leak, stenosis, and severe hypoglycemic episodes, will be recorded during follow-up.","From surgery through 12 months after surgery",{"measure":48,"description":49,"timeFrame":50},"Percentage of Excess Weight Loss","Weight loss will be assessed as the percentage of excess weight loss (%EWL) after bariatric surgery.","3 months, 6 months, and 12 months after surgery",{"measure":52,"description":53,"timeFrame":50},"Percentage of Total Weight Loss","Weight loss will be assessed as the percentage of total weight loss (%TWL) from baseline body weight.",{"measure":55,"description":56,"timeFrame":12},"Mean Amplitude of Glycemic Excursions","Mean amplitude of glycemic excursions (MAGE) will be calculated from continuous glucose monitoring data as a measure of short-term intraday glycemic variability.",{"measure":58,"description":59,"timeFrame":12},"Time in Range","Time in range (TIR) will be calculated from continuous glucose monitoring data as the percentage of time that glucose values are between 70 and 180 mg\u002FdL.",{"measure":61,"description":62,"timeFrame":12},"Mean Glucose Concentration","Mean glucose concentration will be calculated from continuous glucose monitoring data collected over 7 days at each study time point.",{"measure":64,"description":65,"timeFrame":12},"Glucose Standard Deviation","Glucose standard deviation will be calculated from continuous glucose monitoring data collected over 7 days at each study time point as a measure of short-term intraday glycemic variability.",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":70,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":72,"maskingDescription":66,"whoMasked":66},"NONE",[74,80],{"label":75,"type":76,"description":77,"interventionNames":78},"Single Anastomosis Sleeve Ileal Bypass","EXPERIMENTAL","Participants assigned to this arm will undergo Single Anastomosis Sleeve Ileal Bypass (SASI), consisting of sleeve gastrectomy with a single gastroileal anastomosis.",[79],"Procedure: Single Anastomosis Sleeve Ileal Bypass",{"label":81,"type":82,"description":83,"interventionNames":84},"Roux-en-Y Gastric Bypass","ACTIVE_COMPARATOR","Participants assigned to this arm will undergo Roux-en-Y Gastric Bypass (RYGB), consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses.",[85],"Procedure: Roux-en-Y Gastric Bypass",[87,91],{"type":88,"name":75,"description":89,"armGroupLabels":90,"otherNames":66},"PROCEDURE","Bariatric surgical procedure consisting of sleeve gastrectomy with a single gastroileal anastomosis.",[75],{"type":88,"name":81,"description":92,"armGroupLabels":93,"otherNames":66},"Bariatric surgical procedure consisting of gastric pouch creation with gastrojejunal and jejunojejunal anastomoses.",[81],[95],{"name":96,"affiliation":5,"role":97},"Isaías Alarcón del Agua, MD, PhD","PRINCIPAL_INVESTIGATOR",[99],{"name":96,"role":100,"phone":101,"phoneExt":66,"email":102},"CONTACT","+ 34646357875","isaiasalarcon@gmail.com",[104],{"facility":105,"status":106,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"Hospital Universitario Virgen del Rocío","RECRUITING","Seville","Sevilla","41013","Spain","ES",{"type":113,"coordinates":114},"Point",[115,116],-5.97317,37.38283,{"lat":116,"lon":115},[119,121],{"name":96,"role":100,"phone":120,"phoneExt":66,"email":102},"+34646357875",{"name":96,"role":97,"phone":66,"phoneExt":66,"email":66},{"type":123,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100659882","glycemic-variability-after-sasi-versus-roux-en-y-gastric-bypass-100659882",false,"NCT07872397","Glycemic Variability After SASI Versus Roux-en-Y Gastric Bypass","Comparison of Glycemic Variability After Bariatric Surgery With Single Anastomosis Sleeve Ileal Bypass (SASI) Versus Roux-en-Y Gastric Bypass (RYGB) Using Continuous Glucose Monitoring","GLUBARI","Inclusion Criteria:\n\n* Age 18 years or older and younger than 75 years.\n* Morbid obesity with body mass index (BMI) between 35 and 55 kg\u002Fm².\n* Pre-anesthetic assessment classified as ASA I-III.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>55 kg\u002Fm².\n* Previous major gastrointestinal surgery.\n* Diseases that alter interstitial fluid volume and may affect glucose measurement accuracy, including severe acute or chronic renal failure, heart failure, or liver failure.\n* Pathological gastroesophageal reflux disease with endoscopic involvement.\n* Pre-anesthetic assessment not suitable for surgery or ASA IV.\n* Pregnancy.\n* Alcohol addiction.\n* Active malignancy.\n* Refusal to sign informed consent.\n* Inability to comply with study instructions.'","ALL","18 Years","74 Years",{"count":136,"type":137},68,"ESTIMATED","INTERVENTIONAL",[140],"NA","The GLUBARI trial is a prospective, randomized, single-center clinical study comparing two bariatric surgical procedures in adults with morbid obesity: Single Anastomosis Sleeve Ileal Bypass (SASI) and Roux-en-Y Gastric Bypass (RYGB). The main objective is to compare glycemic variability between the two procedures using continuous glucose monitoring. Participants will undergo continuous glucose monitoring for 7 days before surgery and again at 6 and 12 months after surgery. Secondary outcomes include hypoglycemic events, weight loss, resolution of obesity-related comorbidities, postoperative complications, gastroesophageal reflux, nutritional deficiencies, and quality of life. A total of 68 participants will be randomized in a 1:1 ratio to SASI or RYGB and followed for 12 months after surgery.",[143],"Obesity, Morbid",[145,146,147,75,148],"Glycemic Variability","Bariatric Surgery","Continuous Glucose Monitoring","Gastric Bypass","2026-10-07",{"date":151,"type":152},"2026-10-13","ACTUAL",{"date":154,"type":152},"2026-07-14",{"date":156,"type":137},"2028-07",{"name":5,"class":6},1]