Morbid Obesity Clinical Trial
— LAF 28Official title:
Effect of Number of Meals on Metabolism After Weight Loss Surgery
Verified date | January 2017 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as incretin levels. Whether the release of GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in 'real life' setting of multiple small meals diet is unclear.
Status | Completed |
Enrollment | 33 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility |
Inclusion Criteria: morbidly obese individuals, BMI above 35 and less than 50 kg/m2 who
chose GBP as treatment for their obesity - Must be able to attend all study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City - Individuals with or without Type 2 Diabetes Mellitus are eligible Exclusion Criteria: - Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit. - Patients with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. - Currently pregnant or nursing. - Known cardiovascular disease. - Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection - Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study. - past history of severe food allergy - History of Type 1 Diabetes Mellitus - Individuals taking insulin, thiazolidinedione, exenatide, or DPP-IV inhibitors |
Country | Name | City | State |
---|---|---|---|
United States | New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in GLP-1 levels before and after gastric bypass surgery | Investigators will assess GLP-1 levels in subjects pre and post-GBP | 12-15 months | |
Primary | Difference in glucose levels before and after gastric bypass surgery | Investigators will assess glucose in subjects pre and post-GBP | 12-15 months | |
Primary | Difference in insulin levels before and after gastric bypass surgery | Investigators will assess insulin levels in subjects pre and post-GBP | 12-15 months | |
Secondary | Difference in GLP-1 levels in solid vs liquid meals | Investigators will assess GLP-1 levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points | 12-15 months | |
Secondary | Difference in glucose levels in solid vs liquid meals | Investigators will assess glucose levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points | 12-15 months | |
Secondary | Difference in insulin levels in solid vs liquid meals | Investigators will assess insulin levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points | 12-15 months |
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