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

NCT ID: NCT02048501

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-03-31

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.

Conditions

Obesity; Weight Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Weight Regain

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.

Group Type: OTHER

Resting Metabolic Rate (RMR)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Sustained Weight Loss (SWL)

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.

Group Type: OTHER

Resting Metabolic Rate (RMR)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Hologic Discovery A serial # 82364A version 13.3

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chan Park, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Center for Metabolic and Weight Loss Surgery

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00049254

Identifier Type: -

Identifier Source: org_study_id