RYGB and the Gastric Adipose Axis

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT01474785

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Naji Abumrad, Professor of Surgery, Chairman Department of Surgery, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01474785

Other Study ID Numbers:

#111237
R01DK091748

First Posted:

Nov 18, 2011

Last Update Posted:

May 21, 2018

Last Verified:

Jan 1, 2018

Keywords provided by Naji Abumrad, Professor of Surgery, Chairman Department of Surgery, Vanderbilt University

Obesity

Bariatric surgery

Nashville, Tennessee

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of May 21, 2018