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NCT02048501 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
57
Enrollment target

NCT02048501: Completed NA study, sponsored by Duke University.

NCT02048501 is a NA study that has completed, run by Duke University. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02048501, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
57 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

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

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2014-01
Est. Completion 2015-03
Phase NA
Duke University

1,725 total trials

What the finished NCT02048501 record still lists

NCT02048501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 4 interventions - of which Resting Metabolic Rate (RMR) is the first listed.

NCT02048501 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02048501 about?

NCT02048501 is a clinical study titled "Changes in Gut Hormones, Body Composition and Energy Expenditure After Roux-en-Y". 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 ...

What is the current status of trial NCT02048501?

This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2014-01. Estimated completion is 2015-03.

What interventions are being tested in trial NCT02048501?

The interventions under investigation include: Resting Metabolic Rate (RMR) (OTHER), Duel-energy x-ray absorptiometry (DEXA) (OTHER), Visual Analog Scale (VAS) (OTHER), Meal Stimulation Test (OTHER).

Who is sponsoring clinical trial NCT02048501?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02048501's enrollment target sits among peer trials

57 1261st of 2000 higher than 739 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02048501, the US trial registry maintained by the National Library of Medicine. NCT02048501 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.