Effect of Number of Meals on Metabolism After Weight Loss Surgery (LAF 28)

Columbia University

Status: Completed

Conditions: Morbid Obesity

Treatments: Other: Liquid Meal; Other: Multiple, 200 kcal meals; Other: Solid Meal; Drug: Acetaminophen; Other: Single, 600 kcal meal

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02929212

AAAO3051

R01DK067561 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Solid Meal Study Group A

Other group

Description:

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

Treatment:

Other: Solid Meal

Other: Single, 600 kcal meal

Drug: Acetaminophen

Liquid Meal Study Group A

Other group

Description:

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

Treatment:

Other: Liquid Meal

Other: Single, 600 kcal meal

Drug: Acetaminophen

Solid Meal Study Group B

Other group

Description:

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

Treatment:

Other: Solid Meal

Other: Multiple, 200 kcal meals

Drug: Acetaminophen

Liquid Meal Study Group B

Other group

Description:

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

Treatment:

Other: Liquid Meal

Other: Multiple, 200 kcal meals

Drug: Acetaminophen