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

Primary Purpose

Morbid Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Solid Meal

Liquid Meal

Acetaminophen

Single, 600 kcal meal

Multiple, 200 kcal meals

About this trial

This is an interventional basic science trial for Morbid Obesity focused on measuring Gastric Bypass, Meal Texture, Meal Number, GLP-1, Glucose

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Arm Label

Solid Meal Study Group A

Liquid Meal Study Group A

Solid Meal Study Group B

Liquid Meal Study Group B

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Difference in GLP-1 levels before and after gastric bypass surgery

Investigators will assess GLP-1 levels in subjects pre and post-GBP

Difference in glucose levels before and after gastric bypass surgery

Investigators will assess glucose in subjects pre and post-GBP

Difference in insulin levels before and after gastric bypass surgery

Investigators will assess insulin levels in subjects pre and post-GBP

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT02929212

First Posted

October 7, 2016

Last Updated

January 30, 2017

Sponsor

Columbia University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT02929212

Brief Title

Effect of Number of Meals on Metabolism After Weight Loss Surgery

Acronym

LAF 28

Official Title

Effect of Number of Meals on Metabolism After Weight Loss Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Morbid Obesity

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Solid Meal Study Group A

Arm Type

Other

Arm Description

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

Arm Title

Liquid Meal Study Group A

Arm Type

Other

Arm Description

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

Arm Title

Solid Meal Study Group B

Arm Type

Other

Arm Description

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

Arm Title

Liquid Meal Study Group B

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Solid Meal

Intervention Description

Subjects will receive solid meals during meal study

Intervention Type

Other

Intervention Name(s)

Liquid Meal

Intervention Description

Subjects will receive liquid meals, during meal study

Intervention Type

Drug

Intervention Name(s)

Acetaminophen

Intervention Description

All subjects given acetaminophen to measure gastric emptying

Intervention Type

Other

Intervention Name(s)

Single, 600 kcal meal

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Multiple, 200 kcal meals

Intervention Description

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

Primary Outcome Measure Information:

Title

Difference in GLP-1 levels before and after gastric bypass surgery

Description

Investigators will assess GLP-1 levels in subjects pre and post-GBP

Time Frame

12-15 months

Title

Difference in glucose levels before and after gastric bypass surgery

Description

Investigators will assess glucose in subjects pre and post-GBP

Time Frame

12-15 months

Title

Difference in insulin levels before and after gastric bypass surgery

Description

Investigators will assess insulin levels in subjects pre and post-GBP

Time Frame

12-15 months

Secondary Outcome Measure Information:

Title

Difference in GLP-1 levels in solid vs liquid meals

Description

Investigators will assess GLP-1 levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points

Time Frame

12-15 months

Title

Difference in glucose levels in solid vs liquid meals

Description

Investigators will assess glucose levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points

Time Frame

12-15 months

Title

Difference in insulin levels in solid vs liquid meals

Description

Investigators will assess insulin levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points

Time Frame

12-15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Blandine Laferrere, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

New York

State/Province

New York

ZIP/Postal Code

10025

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Number of Meals on Metabolism After Weight Loss Surgery

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