Clinical trial NCT02929212: Effect of Number of Meals on Metabolism After Weight Loss Surgery
Official title: Effect of Number of Meals on Metabolism After Weight Loss Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Gastric Bypass
Meal Texture
Meal Number
GLP-1
Glucose
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-10-11
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Difference in GLP-1 levels before and after gastric bypass surgery
timeFrame: 12-15 months
measure: Difference in glucose levels before and after gastric bypass surgery
timeFrame: 12-15 months
measure: Difference in insulin levels before and after gastric bypass surgery
timeFrame: 12-15 months
Secondary outcomes:
measure: Difference in GLP-1 levels in solid vs liquid meals
timeFrame: 12-15 months
measure: Difference in glucose levels in solid vs liquid meals
timeFrame: 12-15 months
measure: Difference in insulin levels in solid vs liquid meals
timeFrame: 12-15 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center
state: New York
Study officials:
affiliation: Columbia University
name: Blandine Laferrere, MD
role: PRINCIPAL_INVESTIGATOR
References: