RYGB and the Gastric Adipose Axis

Phase 1

Completed

• Conditions: Obesity
• Interventions: Other: very low calorie diet; Drug: human ghrelin; Procedure: Hyperinsulinemic/Euglycemic Clamp

• Registration Number: NCT01474785
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-18
• Study Start: 2012-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGB	Hyperinsulinemic/Euglycemic Clamp	Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.
VSG	Hyperinsulinemic/Euglycemic Clamp	Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively.
Low Calorie Diet	very low calorie diet	Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.
Low Calorie Diet	Hyperinsulinemic/Euglycemic Clamp	Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.
RYGB	human ghrelin	Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States