Effect of Number of Meals on Metabolism After Weight Loss Surgery

NCT ID: NCT02929212

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2014-04-30

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Solid Meal Study Group A

Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as one, 600 kcal, meal.

Group Type: OTHER

Solid Meal

Intervention Type: OTHER

Subjects will receive solid meals during meal study

Acetaminophen

Intervention Type: DRUG

All subjects given acetaminophen to measure gastric emptying

Single, 600 kcal meal

Intervention Type: OTHER

Subjects will receive a single, 600 kcal meal during meal study

Liquid Meal Study Group A

Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as one, 600 kcal, meal

Group Type: OTHER

Liquid Meal

Intervention Type: OTHER

Subjects will receive liquid meals, during meal study

Acetaminophen

Intervention Type: DRUG

All subjects given acetaminophen to measure gastric emptying

Single, 600 kcal meal

Intervention Type: OTHER

Subjects will receive a single, 600 kcal meal during meal study

Solid Meal Study Group B

Patients Pre and Post-GBP who are randomly assigned to receive solid meals on study days given as three, 200 kcal, meals.

Group Type: OTHER

Solid Meal

Intervention Type: OTHER

Subjects will receive solid meals during meal study

Acetaminophen

Intervention Type: DRUG

All subjects given acetaminophen to measure gastric emptying

Multiple, 200 kcal meals

Intervention Type: OTHER

Subjects will receive three, 200 kcal meals, during meal study

Liquid Meal Study Group B

Patients Pre and Post-GBP who are randomly assigned to receive liquid meals on meal study days, given as three, 200 kcal, meals.

Group Type: OTHER

Liquid Meal

Intervention Type: OTHER

Subjects will receive liquid meals, during meal study

Acetaminophen

Intervention Type: DRUG

All subjects given acetaminophen to measure gastric emptying

Multiple, 200 kcal meals

Intervention Type: OTHER

Subjects will receive three, 200 kcal meals, during meal study

Interventions

Solid Meal

Subjects will receive solid meals during meal study

Intervention Type: OTHER

Liquid Meal

Subjects will receive liquid meals, during meal study

Intervention Type: OTHER

Acetaminophen

All subjects given acetaminophen to measure gastric emptying

Intervention Type: DRUG

Single, 600 kcal meal

Subjects will receive a single, 600 kcal meal during meal study

Intervention Type: OTHER

Multiple, 200 kcal meals

Subjects will receive three, 200 kcal meals, during meal study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Blandine Laferrere

Professor of Medicine, Columbia University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Blandine Laferrere, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Countries

United States

Other Identifiers

R01DK067561

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAO3051

Identifier Type: -

Identifier Source: org_study_id