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

Duke University

Status: Completed

Conditions: Weight Loss; Obesity

Treatments: Other: Meal Stimulation Test; Other: Resting Metabolic Rate (RMR); Other: Duel-energy x-ray absorptiometry (DEXA); Other: Visual Analog Scale (VAS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02048501

Pro00049254

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Weight Regain

Other group

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.

Treatment:

Other: Duel-energy x-ray absorptiometry (DEXA)

Other: Meal Stimulation Test

Other: Resting Metabolic Rate (RMR)

Other: Visual Analog Scale (VAS)

Sustained Weight Loss (SWL)

Other group

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.

Treatment:

Other: Duel-energy x-ray absorptiometry (DEXA)

Other: Meal Stimulation Test

Other: Resting Metabolic Rate (RMR)

Other: Visual Analog Scale (VAS)