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Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery

NCT ID: NCT01938469

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-07-31

Brief Summary

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Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP).

Detailed Description

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The main goal is to study the effect of meal number, size and texture on metabolism and 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 isocaloric meals, with the order of the conditions randomly assigned. The total amount of calories and the overall nutrient composition 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.

Gastric emptying will be measured by the acetaminophen test.

Conditions

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Gastric Bypass Surgery Obesity

Keywords

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Bariatric Gastric Bypass Gastric Banding, Incretins glucagon-like peptide-1(GLP-1) gastric inhibitory peptide (GIP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Solid Meal

Participants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).

Group Type OTHER

Solid Meal

Intervention Type OTHER

Liquid Meal

Participants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).

Group Type OTHER

Liquid Meal

Intervention Type OTHER

Interventions

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Liquid Meal

Intervention Type OTHER

Solid Meal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Severely obese patients undergoing gastric bypass surgery (GBP)
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blandine Laferrere, MD

Role: PRINCIPAL_INVESTIGATOR

New York Obesity Nutrition Research Center

Locations

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St. Lukes- Roosevelt Hospital- New York Obesity Research Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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09-117

Identifier Type: -

Identifier Source: org_study_id