NCT01474785

RYGB and the Gastric Adipose Axis

RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-11-18
• Last updated: 2018-05-21

Locations

1 site across 1 country: United States