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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048501
• Other study ID #: Pro00049254
• Status: Completed
• Phase: N/A
• First received: January 27, 2014
• Last updated: April 25, 2017
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Duke Center for Metabolic and Weight Loss Surgery	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Prior to meal stimulation test, 30 minutes, 60 minutes, 90 minutes and 120 after the meal stimulation test.
Primary	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.	Priot to the meal stimulation test, 30 minutes,60 minutes, 90 minutes, and 120 minutes after the meal stimulation test.