Morbid Obesity
Conditions
Keywords
Gastric Bypass, Meal Texture, Meal Number, GLP-1, Glucose
Brief summary
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.
Detailed description
The main goal is to study the effect of meal size and texture on incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small meals, with the order of the conditions randomly assigned. The total amount of calories (600 kcal) and the over all nutrient composition (55% CHO, 15 % protein, 30% fat) will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals. Recruitment and data gathering for this study were performed at St. Luke's Hospital in New York, NY. Data Analysis was performed at Columbia University Medical Center in New York, NY.
Interventions
OTHERSolid Meal
Subjects will receive solid meals during meal study
OTHERLiquid Meal
Subjects will receive liquid meals, during meal study
DRUGAcetaminophen
All subjects given acetaminophen to measure gastric emptying
OTHERSingle, 600 kcal meal
Subjects will receive a single, 600 kcal meal during meal study
OTHERMultiple, 200 kcal meals
Subjects will receive three, 200 kcal meals, during meal study
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in GLP-1 levels before and after gastric bypass surgery | 12-15 months | Investigators will assess GLP-1 levels in subjects pre and post-GBP |
| Difference in glucose levels before and after gastric bypass surgery | 12-15 months | Investigators will assess glucose in subjects pre and post-GBP |
| Difference in insulin levels before and after gastric bypass surgery | 12-15 months | Investigators will assess insulin levels in subjects pre and post-GBP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in GLP-1 levels in solid vs liquid meals | 12-15 months | Investigators will assess GLP-1 levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points |
| Difference in glucose levels in solid vs liquid meals | 12-15 months | Investigators will assess glucose levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points |
| Difference in insulin levels in solid vs liquid meals | 12-15 months | Investigators will assess insulin levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points |
Countries
United States
Outcome results
None listed