Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-01-20 @ 5:40 PM
Study NCT ID:
NCT01429506
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2011-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-23', 'studyFirstSubmitDate': '2011-09-04', 'studyFirstSubmitQcDate': '2011-09-06', 'lastUpdatePostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '6 months', 'description': 'weight loss at 6 months after the start of intervention'}], 'secondaryOutcomes': [{'measure': 'glycemic control', 'timeFrame': '6 months', 'description': 'HbA1c and glucose profile'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleeve gastrectomy', 'Intensive medical management'], 'conditions': ['Diabetes Mellitus', 'Obesity']}, 'descriptionModule': {'briefSummary': 'In this the investigators will be comparing the effects of Laparoscopic sleeve gastrectomy with intensive medical management on weight and metabolic parameters.', 'detailedDescription': 'Intensive medical management will include\n\n1. VLCD\n2. Physical activity\n3. Exenatide\n4. Metformin\n5. Insulin detemir'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nType 2 Diabetics with\n\n1. BMI ≥ 27.5 kg/m2\n2. HbA1c 7-10%\n3. Age 20-70 years\n\nExclusion Criteria:\n\n1. Prior gastric surgery\n2. Pregnancy and lactation\n3. renal disease (GFR \\< 60 ml/min)\n4. Pancreatitis\n5. Symptomatic gallstone disease\n6. Active malignancy\n7. Secondary causes of obesity ( Cushing's syndrome, uncontrolled Hypothyroidism)\n8. Severe psychiatric illness\n9. Allergic reaction to exenatide"}, 'identificationModule': {'nctId': 'NCT01429506', 'briefTitle': 'Efficacy of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'officialTitle': 'Effect of Laparoscopic Sleeve Gastrectomy and Intensive Medical Management in Obese Type 2 Diabetes', 'orgStudyIdInfo': {'id': '922861'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sleeve gastrectomy', 'description': 'Will undergo laparoscopic sleeve gastrectomy', 'interventionNames': ['Procedure: Sleeve gastrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive medical management', 'description': 'Will receive VLCD, exenatide, metformin, insulin detemir', 'interventionNames': ['Drug: Intensive medical management']}], 'interventions': [{'name': 'Sleeve gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Bariatric surgery', 'Laparoscopic sleeve gastrectomy'], 'description': 'Sleeve gastrectomy', 'armGroupLabels': ['Sleeve gastrectomy']}, {'name': 'Intensive medical management', 'type': 'DRUG', 'description': 'Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet', 'armGroupLabels': ['Intensive medical management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'country': 'India', 'facility': 'PGIMER', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'overallOfficials': [{'name': 'Anil Bhansali, DM, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of endocrinology', 'investigatorFullName': 'Anil Bhansali', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}