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OpenTrials
Completed

NCT Number: NCT01474785

RYGB and the Gastric Adipose Axis

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 34232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human ghrelin

Drug

0.5-1 pmol/kg.min of human ghrelin administered by IV two times

very low calorie diet

Other

standard very low calorie diet that is prescribed for all RYGB patients after their operation

Hyperinsulinemic/Euglycemic Clamp

Procedure

Insulin and glucose infusions to measure glucose kinetics.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

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

Registry information

Official study title

RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2011
Registry last updated
May 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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