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

Not Applicable

Completed

• Conditions: Obesity; Weight Loss
• Interventions: Other: Resting Metabolic Rate (RMR); Other: Duel-energy x-ray absorptiometry (DEXA); Other: Visual Analog Scale (VAS); Other: Meal Stimulation Test

• Registration Number: NCT02048501
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sustained Weight Loss (SWL)	Duel-energy x-ray absorptiometry (DEXA)	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.
Weight Regain	Meal Stimulation Test	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.
Weight Regain	Visual Analog Scale (VAS)	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.
Sustained Weight Loss (SWL)	Visual Analog Scale (VAS)	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.
Weight Regain	Resting Metabolic Rate (RMR)	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.
Weight Regain	Duel-energy x-ray absorptiometry (DEXA)	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.
Sustained Weight Loss (SWL)	Resting Metabolic Rate (RMR)	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.
Sustained Weight Loss (SWL)	Meal Stimulation Test	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.

Primary Outcome Measures

Name	Time	Method
Difference in pre and post-prandial plasma Glucagon-like peptide-1 (GLP-1)	Prior to meal stimulation test, 30 minutes, 60 minutes, 90 minutes and 120 after the meal stimulation test.	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)	Priot to the meal stimulation test, 30 minutes,60 minutes, 90 minutes, and 120 minutes after the meal stimulation test.	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.

Trial Locations

Locations (1)

Duke Center for Metabolic and Weight Loss Surgery; 🇺🇸 Durham, North Carolina, United States