Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-26 @ 2:23 AM
Study NCT ID:
NCT00571220
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2007-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Diabetes Control After Weight Loss Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2007-12-07', 'studyFirstSubmitQcDate': '2007-12-07', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in incretin', 'timeFrame': 'One month', 'description': 'Change in incretin (gastric inhibitory peptide \\[GIP\\] and glucagon-like peptide-1 \\[GLP-1\\])'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric bypass', 'diabetes', 'obesity', 'diet-induced weight loss', 'incretin levels (GLP-1,GIP)', 'incretin effect'], 'conditions': ['Gastric Bypass Surgery', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '17416796', 'type': 'RESULT', 'citation': 'Laferrere B, Heshka S, Wang K, Khan Y, McGinty J, Teixeira J, Hart AB, Olivan B. Incretin levels and effect are markedly enhanced 1 month after Roux-en-Y gastric bypass surgery in obese patients with type 2 diabetes. Diabetes Care. 2007 Jul;30(7):1709-16. doi: 10.2337/dc06-1549. Epub 2007 Apr 6.'}, {'pmid': '24296713', 'type': 'DERIVED', 'citation': 'Dutia R, Brakoniecki K, Bunker P, Paultre F, Homel P, Carpentier AC, McGinty J, Laferrere B. Limited recovery of beta-cell function after gastric bypass despite clinical diabetes remission. Diabetes. 2014 Apr;63(4):1214-23. doi: 10.2337/db13-1176. Epub 2013 Dec 2.'}, {'pmid': '20501690', 'type': 'DERIVED', 'citation': 'Laferrere B, Swerdlow N, Bawa B, Arias S, Bose M, Olivan B, Teixeira J, McGinty J, Rother KI. Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):4072-6. doi: 10.1210/jc.2009-2767. Epub 2010 May 25.'}]}, 'descriptionModule': {'briefSummary': "Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Morbidly obese patients with type 2 diabetes of less than 5 years duration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet.\n\nExclusion Criteria:\n\n* any condition that would be contra-indicated for bariatric surgery (ex:unstable angina)\n* diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors\n* HbA1C \\> 8%'}, 'identificationModule': {'nctId': 'NCT00571220', 'briefTitle': 'Mechanisms of Diabetes Control After Weight Loss Surgery', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Mechanisms of Diabetes Control After Weight Loss Surgery', 'orgStudyIdInfo': {'id': 'DK67561 (completed)'}, 'secondaryIdInfos': [{'id': 'R01DK067561', 'link': 'https://reporter.nih.gov/quickSearch/R01DK067561', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric bypass surgery', 'description': 'Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery', 'interventionNames': ['Procedure: gastric bypass surgery']}, {'label': 'Diet induced weight loss', 'description': 'Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age.', 'interventionNames': ['Other: Diet induced weight loss']}], 'interventions': [{'name': 'gastric bypass surgery', 'type': 'PROCEDURE', 'description': 'weight loss bariatric surgery', 'armGroupLabels': ['Gastric bypass surgery']}, {'name': 'Diet induced weight loss', 'type': 'OTHER', 'description': 'low calorie diet with meal replacements. weekly outpatient visits with nutritionist.', 'armGroupLabels': ['Diet induced weight loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St Luke's Roosevelt Hospital Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Blandine Laferrere, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's-Roosevelt Hospital Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}