NCT02048501

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

January 27, 2014

Last Update Submit

April 25, 2017

Conditions

ObesityWeight Loss

Keywords

Weight regainSustain weight lossWeight lossGut hormones

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Weight Regain

OTHER

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.

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

Sustained Weight Loss (SWL)

OTHER

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.

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

Interventions

Resting Metabolic Rate (RMR)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.

Sustained Weight Loss (SWL)Weight Regain
Duel-energy x-ray absorptiometry (DEXA)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.

Also known as: Hologic Discovery A serial # 82364A version 13.3
Sustained Weight Loss (SWL)Weight Regain
Visual Analog Scale (VAS)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.

Sustained Weight Loss (SWL)Weight Regain
Meal Stimulation TestOTHER

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)Weight Regain

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-65 years of age
  • Ability and willingness to provide informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Center for Metabolic and Weight Loss Surgery

Durham, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Basal Metabolism

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Energy MetabolismMetabolism

Study Officials

  • Chan Park, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2014

First Posted

January 29, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

US(1)