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NCT01474785 · ClinicalTrials.gov registry record · Phase 1

RYGB and the Gastric Adipose Axis

A Phase 1 study, sponsored by Vanderbilt University.

Completed
Registry status
Phase 1
Development phase
49
Enrollment target

NCT01474785: Completed Phase 1 study, sponsored by Vanderbilt University.

NCT01474785 is a Phase 1 study that has completed, run by Vanderbilt University. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01474785, a Phase 1 study, has completed, sponsored by Vanderbilt University.

COMPLETED
Registry status
Phase 1
Development phase
49 participants
Enrollment target

Study Summary

The purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG) and in an altered acylated ghrelin:unacylated ghrelin (AG:UAG) ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.

Primary Outcome

Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity).

Interventions

  • DRUG human ghrelin
  • OTHER very low calorie diet
  • PROCEDURE Hyperinsulinemic/Euglycemic Clamp

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2012-01
Est. Completion 2015-07
Phase Phase 1
Vanderbilt University

430 total trials

What the finished NCT01474785 record still lists

NCT01474785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).

The record links to 0 conditions, and to 3 interventions - of which human ghrelin is the first listed.

NCT01474785 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01474785 about?

NCT01474785 is a clinical study titled "RYGB and the Gastric Adipose Axis". The purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in RYGB results in reduction of plasma acylated ghrelin (AG...

What is the current status of trial NCT01474785?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-01. Estimated completion is 2015-07.

What interventions are being tested in trial NCT01474785?

The interventions under investigation include: human ghrelin (DRUG), very low calorie diet (OTHER), Hyperinsulinemic/Euglycemic Clamp (PROCEDURE).

Who is sponsoring clinical trial NCT01474785?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01474785's enrollment target sits among peer trials

49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01474785, the US trial registry maintained by the National Library of Medicine. NCT01474785 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.