Effect of Number of Meals on Metabolism After Weight Loss Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Number of Meals on Metabolism After Weight Loss Surgery

Conditions
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Morbid Obesity

Intervention / Treatment
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* Other: Solid Meal
* Other: Liquid Meal
* Drug: Acetaminophen
* Other: Single, 600 kcal meal
* Other: Multiple, 200 kcal meals


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Solid Meal Study Group A<br>Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal. | Other: Solid Meal<br>* Subjects will receive solid meals during meal study<br>Drug: Acetaminophen<br>* All subjects given acetaminophen to measure gastric emptying<br>Other: Single, 600 kcal meal<br>* Subjects will receive a single, 600 kcal meal during meal study<br>|
| Other: Liquid Meal Study Group A<br>Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal | Other: Liquid Meal<br>* Subjects will receive liquid meals, during meal study<br>Drug: Acetaminophen<br>* All subjects given acetaminophen to measure gastric emptying<br>Other: Single, 600 kcal meal<br>* Subjects will receive a single, 600 kcal meal during meal study<br>|
| Other: Solid Meal Study Group B<br>Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals. | Other: Solid Meal<br>* Subjects will receive solid meals during meal study<br>Drug: Acetaminophen<br>* All subjects given acetaminophen to measure gastric emptying<br>Other: Multiple, 200 kcal meals<br>* Subjects will receive three, 200 kcal meals, during meal study<br>|
| Other: Liquid Meal Study Group B<br>Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals. | Other: Liquid Meal<br>* Subjects will receive liquid meals, during meal study<br>Drug: Acetaminophen<br>* All subjects given acetaminophen to measure gastric emptying<br>Other: Multiple, 200 kcal meals<br>* Subjects will receive three, 200 kcal meals, during meal study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Difference in glucose levels before and after gastric bypass surgery | Investigators will assess glucose in subjects pre and post-GBP | 12-15 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, Gastric Bypass, Meal Texture, Meal Number, Glucose