RYGB and the Gastric Adipose Axis

RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01474785

Enrollment

Registered

2011-11-18

Start date

2012-01-31

Completion date

2015-07-31

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Obesity, Bariatric surgery, Nashville, Tennessee

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.

Interventions

DRUGhuman ghrelin

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

OTHERvery low calorie diet

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

PROCEDUREHyperinsulinemic/Euglycemic Clamp

Insulin and glucose infusions to measure glucose kinetics.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026