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RYGB and the Gastric Adipose Axis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474785
First Posted: November 18, 2011
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Naji Abumrad, Vanderbilt University
  Purpose
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.

Condition Intervention Phase
Obesity Drug: human ghrelin Other: very low calorie diet Procedure: Hyperinsulinemic/Euglycemic Clamp Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis

Further study details as provided by Naji Abumrad, Vanderbilt University:

Primary Outcome Measures:
  • change in glucose disposal rate [ Time Frame: baseline and 1 week ]
    Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity).


Enrollment: 49
Study Start Date: January 2012
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RYGB
Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.
Drug: human ghrelin
0.5-1 pmol/kg.min of human ghrelin administered by IV two times
Procedure: Hyperinsulinemic/Euglycemic Clamp
Insulin and glucose infusions to measure glucose kinetics.
Experimental: VSG
Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively.
Procedure: Hyperinsulinemic/Euglycemic Clamp
Insulin and glucose infusions to measure glucose kinetics.
Experimental: Low Calorie Diet
Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL I

Inclusion Criteria:

  • Age 18-65 years
  • BMI ≥ 35 kg/m^2
  • Scheduled for bariatric surgery
  • Considering bariatric surgery
  • Waiting for insurance approval for bariatric surgery
  • Currently not considering bariatric surgery, but otherwise eligible
  • Enrollment in medical weight loss program

Exclusion Criteria:

  • Smoking >7 cigarettes per day
  • Precious malabsorptive or restrictive intestinal surgery
  • Pregnant or breastfeeding
  • Recent history of neoplasia (5<years ago)
  • Malabsorptive syndromes
  • Inflammatory intestinal disease
  • Established organ disfunction
  • Allergy to acetaminophen
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01474785


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 34232
Sponsors and Collaborators
Vanderbilt University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Naji Abumrad, MD Vanderbilt University Medical Center
Study Director: Robyn Tamboli, PhD Vanderbilt University Medical Center
  More Information

Responsible Party: Naji Abumrad, Professor of Surgery, Chairman Department of Surgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01474785     History of Changes
Other Study ID Numbers: #111237
R01DK091748 ( U.S. NIH Grant/Contract )
First Submitted: November 15, 2011
First Posted: November 18, 2011
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Naji Abumrad, Vanderbilt University:
Obesity
Bariatric surgery
Nashville, Tennessee