RYGB and the Gastric Adipose Axis

Vanderbilt University

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: human ghrelin; Other: very low calorie diet; Procedure: Hyperinsulinemic/Euglycemic Clamp

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01474785

#111237

R01DK091748 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

RYGB

Experimental group

Description:

Roux-en-Y gastric bypass surgery (RYGB) subjects to undergo hyperinsulinemic-euglycemic clamp with human ghrelin infusion pre-operatively and post-operatively.

Treatment:

Procedure: Hyperinsulinemic/Euglycemic Clamp

Drug: human ghrelin

VSG

Experimental group

Description:

Vertical sleeve gastrectomy (VSG) subjects to undergo hyperinsulinemic-euglycemic clamp pre-operatively and post-operatively.

Treatment:

Procedure: Hyperinsulinemic/Euglycemic Clamp

Low Calorie Diet

Experimental group

Description:

Subjects will receive very low calorie diet prescribed for RYGB patients and undergo hyperinsulinemic-euglycemic before and after diet.

Treatment:

Other: very low calorie diet

Procedure: Hyperinsulinemic/Euglycemic Clamp