Effect of Number of Meals on Metabolism After Weight Loss Surgery

Morbid Obesity Clinical Trial

— LAF 28  

Official title:

Effect of Number of Meals on Metabolism After Weight Loss Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929212
• Other study ID #: AAAO3051
• Secondary ID: R01DK067561
• Status: Completed
• Phase: N/A
• First received: October 7, 2016
• Last updated: January 30, 2017
• Start date: September 2009
• Est. completion date: April 2014

Study information

• Verified date: January 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

Other:
• Solid Meal
Subjects will receive solid meals during meal study
• Liquid Meal
Subjects will receive liquid meals, during meal study

Drug:
• Acetaminophen
All subjects given acetaminophen to measure gastric emptying

Other:
• Single, 600 kcal meal
Subjects will receive a single, 600 kcal meal during meal study
• Multiple, 200 kcal meals
Subjects will receive three, 200 kcal meals, during meal study

Locations

Country	Name	City	State
United States	New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Difference in glucose levels before and after gastric bypass surgery	Investigators will assess glucose in subjects pre and post-GBP	12-15 months
Primary	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	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
Secondary	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
Secondary	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