Effect of Number of Meals on Metabolism After Weight Loss Surgery

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Other: Solid Meal; Other: Liquid Meal; Drug: Acetaminophen; Other: Single, 600 kcal meal; Other: Multiple, 200 kcal meals

• Registration Number: NCT02929212
• Lead Sponsor: Columbia University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solid Meal Study Group A	Solid Meal	Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal.
Solid Meal Study Group A	Acetaminophen	Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal.
Solid Meal Study Group A	Single, 600 kcal meal	Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal.
Liquid Meal Study Group A	Liquid Meal	Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal
Liquid Meal Study Group A	Acetaminophen	Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal
Liquid Meal Study Group A	Single, 600 kcal meal	Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal
Solid Meal Study Group B	Solid Meal	Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals.
Solid Meal Study Group B	Multiple, 200 kcal meals	Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals.
Liquid Meal Study Group B	Liquid Meal	Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals.
Liquid Meal Study Group B	Acetaminophen	Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals.
Liquid Meal Study Group B	Multiple, 200 kcal meals	Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals.
Solid Meal Study Group B	Acetaminophen	Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States