Effect of Number of Meals on Metabolism After Weight Loss Surgery

NCT02929212 | Completed DMC

• 2 other identifiers: AAAO3051R01DK067561
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Gastric Bypass; Meal Texture; Meal Number; GLP-1; Glucose

Outcome Measures

Primary Outcomes (3)

• 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

• Difference in glucose levels before and after gastric bypass surgery

  Investigators will assess glucose in subjects pre and post-GBP

  12-15 months

• 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 Outcomes (3)

• Difference in GLP-1 levels in solid vs liquid meals

  12-15 months

• Difference in glucose levels in solid vs liquid meals

  12-15 months

• Difference in insulin levels in solid vs liquid meals

  12-15 months

Study Arms (4)

Solid Meal Study Group A

OTHER

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

Other: Solid Meal; Drug: Acetaminophen; Other: Single, 600 kcal meal

Liquid Meal Study Group A

OTHER

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

Other: Liquid Meal; Drug: Acetaminophen; Other: Single, 600 kcal meal

Solid Meal Study Group B

OTHER

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

Other: Solid Meal; Drug: Acetaminophen; Other: Multiple, 200 kcal meals

Liquid Meal Study Group B

OTHER

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

Other: Liquid Meal; Drug: Acetaminophen; Other: Multiple, 200 kcal meals

Interventions

Solid Meal OTHER

Subjects will receive solid meals during meal study

Solid Meal Study Group A; Solid Meal Study Group B

Liquid Meal OTHER

Subjects will receive liquid meals, during meal study

Liquid Meal Study Group A; Liquid Meal Study Group B

Acetaminophen DRUG

All subjects given acetaminophen to measure gastric emptying

Liquid Meal Study Group A; Liquid Meal Study Group B; Solid Meal Study Group A; Solid Meal Study Group B

Single, 600 kcal meal OTHER

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

Liquid Meal Study Group A; Solid Meal Study Group A

Multiple, 200 kcal meals OTHER

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

Liquid Meal Study Group B; Solid Meal Study Group B

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

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

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Acetaminophen; Single Person; Meals

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Blandine Laferrere, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Columbia University

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 11, 2016
• Study Start: September 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)