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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Other: Solid Meal; Drug: Acetaminophen; Other: Single, 600 kcal meal; Other: Liquid Meal; Other: Multiple, 200 kcal meals

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10025
      • New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: Solid Meal; Subjects will receive solid 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
Other: 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	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; Other: Liquid Meal; Subjects will receive liquid meals, during meal study
Other: 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.	Other: Solid Meal; Subjects will receive solid meals during meal study; Drug: Acetaminophen; All subjects given acetaminophen to measure gastric emptying; Other: Multiple, 200 kcal meals; Subjects will receive three, 200 kcal meals, during meal study
Other: 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.	Drug: Acetaminophen; All subjects given acetaminophen to measure gastric emptying; Other: Liquid Meal; Subjects will receive liquid meals, during meal study; Other: Multiple, 200 kcal meals; Subjects will receive three, 200 kcal meals, during meal study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 11, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: GLP-1; Glucose; Gastric Bypass; Meal Texture; Meal Number
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Obesity, Morbid; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: AAAO3051; R01DK067561 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No