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Changes in Gut Hormones, Body Composition and Energy Expenditure After Roux-en-Y

Primary Purpose

Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resting Metabolic Rate (RMR)
Duel-energy x-ray absorptiometry (DEXA)
Visual Analog Scale (VAS)
Meal Stimulation Test
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Weight regain, Sustain weight loss, Weight loss, Gut hormones

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age between 18-65 years of age
  2. Ability and willingness to provide informed consent

Exclusion Criteria:

  1. Surgical/anatomical failure such as pouch enlargement, anastomosis dilation, formation of a gastrogastric fistula,
  2. Currently on medication that might affect weight gain including GLP-1 analog
  3. Inability to provide informed written consent.
  4. Any known history of abnormal thyroid function.
  5. Females who are pregnant.

Sites / Locations

  • Duke Center for Metabolic and Weight Loss Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Weight Regain

Sustained Weight Loss (SWL)

Arm Description

The weight regain group will include 20 subjects who underwent Roux-en-Y gastric bypass (RYGB) with a follow up of at least 2 years and have experienced excess weight loss (EWL) of at least 50% at 12 (+ 2) months post-operatively and regained at least 15% of the post-operative nadir weight.

The sustained weight loss group will include 20 subjects who underwent Roux-en-Y gastric bypass (RYGB) with a follow up of at least 2 years and have experienced excess weight loss (EWL) of at least 50% at 12 (+ 2) months post-operatively and have regained less than 15% of the post-operative nadir weight.

Outcomes

Primary Outcome Measures

Difference in pre and post-prandial plasma Glucagon-like peptide-1 (GLP-1)
The primary endpoints are a difference in pre postprandial plasma GLP-1 and PYY in subjects who underwent RYGB who succeed or fail to lose and maintain EWL goal.
Difference in pre and post-prandial Peptide YY (PYY)
The primary endpoints are a difference in pre postprandial plasma GLP-1 and PYY in subjects who underwent RYGB who succeed or fail to lose and maintain EWL goal.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2014
Last Updated
April 25, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02048501
Brief Title
Changes in Gut Hormones, Body Composition and Energy Expenditure After Roux-en-Y
Official Title
Gut Hormone, Energy Expenditure and Body Composition Change in Subjects Who Succeed or Fail to Sustain Weight Loss After Roux-en-Y Gastric Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to gain a better understanding of the mechanism of weight regain through gut hormone (substances in the gut that control various functions of the digestive organs) and energy expenditure (the amount of energy a person uses to complete bodily activities). Our hypothesis is that gut hormone response might be different among subjects who are able to maintain weight loss and subjects with weight regain. For this study, investigators will measure fasting and postprandial (happening after a meal) gut hormones, bile acid, amino acids, vitamin B, vitamin D, myokines and adipokine levels in obese individuals who are at least 2 years after a Roux-en-Y gastric bypass (RYGB). Investigators will also measure resting metabolic rate (RMR) (the amount of energy expended daily) and body composition (the proportion of fat, muscle, and bone of an individual's body). The subjects body composition will be analyzed, including fat mass and fat free mass, by a Dual-Energy X-ray Absorptiometry (DEXA). This study will provide more information regarding the effect of RYGB on gut hormones, adipokines, bile acids, amino acids, and energy expenditure and body compositions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Weight regain, Sustain weight loss, Weight loss, Gut hormones

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weight Regain
Arm Type
Other
Arm Description
The weight regain group will include 20 subjects who underwent Roux-en-Y gastric bypass (RYGB) with a follow up of at least 2 years and have experienced excess weight loss (EWL) of at least 50% at 12 (+ 2) months post-operatively and regained at least 15% of the post-operative nadir weight.
Arm Title
Sustained Weight Loss (SWL)
Arm Type
Other
Arm Description
The sustained weight loss group will include 20 subjects who underwent Roux-en-Y gastric bypass (RYGB) with a follow up of at least 2 years and have experienced excess weight loss (EWL) of at least 50% at 12 (+ 2) months post-operatively and have regained less than 15% of the post-operative nadir weight.
Intervention Type
Other
Intervention Name(s)
Resting Metabolic Rate (RMR)
Intervention Description
Each subject will have their resting metabolic rate (RMR) measured. The RMR is assessed by indirect calorimetry measured with the metabolic cart. Oxygen consumption is converted into kilocalories. Subjects will be advised to avoid strenuous exercise for at least 48 hours prior to participation in the study and to sleep at least 6-8 hours the night before. Smoking and consuming caffeine will be prohibited 12 hours before the study begins.
Intervention Type
Other
Intervention Name(s)
Duel-energy x-ray absorptiometry (DEXA)
Other Intervention Name(s)
Hologic Discovery A serial # 82364A version 13.3
Intervention Description
During a separate appointment on the same day, or within 7 business days if same day is not possible, a body compositions analysis, including fat mass and fat free mass, will be assessed by dual-energy x-ray absorptiometry (DEXA), using a Hologic system.
Intervention Type
Other
Intervention Name(s)
Visual Analog Scale (VAS)
Intervention Description
Subjects will be asked to complete a 100-mm Visual Analog scale (VAS) to assess their appetite. The VAS will be completed prior to the meal stimulation test and at 30-minutes, 1-hour, 90 minutes and 2-hours after the meal. The VAS will contain questions assessing food intake, appetite, and hunger.
Intervention Type
Other
Intervention Name(s)
Meal Stimulation Test
Intervention Description
Subjects will consume a mixed-nutrient liquid meal 240-ml in 20 minutes. Prior to the meal stimulation test, a baseline 10-ml blood sample will be collected. The, during the meal stimulation test, 10-ml venous blood sample will be collected at 30 minute intervals up to two hours, for a total of 5 samples including the baseline sample. The blood samples will be used to measure fasting blood glucose, adipokines, myokines, gut hormones, amino acids, bile acids, vitamin B and vitamin D analysis with the appropriate assay method.
Primary Outcome Measure Information:
Title
Difference in pre and post-prandial plasma Glucagon-like peptide-1 (GLP-1)
Description
The primary endpoints are a difference in pre postprandial plasma GLP-1 and PYY in subjects who underwent RYGB who succeed or fail to lose and maintain EWL goal.
Time Frame
Prior to meal stimulation test, 30 minutes, 60 minutes, 90 minutes and 120 after the meal stimulation test.
Title
Difference in pre and post-prandial Peptide YY (PYY)
Description
The primary endpoints are a difference in pre postprandial plasma GLP-1 and PYY in subjects who underwent RYGB who succeed or fail to lose and maintain EWL goal.
Time Frame
Priot to the meal stimulation test, 30 minutes,60 minutes, 90 minutes, and 120 minutes after the meal stimulation test.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-65 years of age Ability and willingness to provide informed consent Exclusion Criteria: Surgical/anatomical failure such as pouch enlargement, anastomosis dilation, formation of a gastrogastric fistula, Currently on medication that might affect weight gain including GLP-1 analog Inability to provide informed written consent. Any known history of abnormal thyroid function. Females who are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chan Park, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Center for Metabolic and Weight Loss Surgery
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States

12. IPD Sharing Statement

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Changes in Gut Hormones, Body Composition and Energy Expenditure After Roux-en-Y

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