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RYGB and the Gastric Adipose Axis

NCT01474785 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-05-21

No results posted yet for this 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.

Conditions

Interventions

DRUG

human ghrelin

0.5-1 pmol/kg.min of human ghrelin administered by IV two times

OTHER

very low calorie diet

standard very low calorie diet that is prescribed for all RYGB patients after their operation

PROCEDURE

Hyperinsulinemic/Euglycemic Clamp

Insulin and glucose infusions to measure glucose kinetics.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Naji Abumrad, MD · Vanderbilt University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474785 on ClinicalTrials.gov