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RYGB and the Gastric Adipose Axis

Primary Purpose

Obesity

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

human ghrelin

very low calorie diet

Hyperinsulinemic/Euglycemic Clamp

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Bariatric surgery, Nashville, Tennessee

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

RYGB

VSG

Low Calorie Diet

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

change in glucose disposal rate

Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity).

Secondary Outcome Measures

Full Information

NCT ID

NCT01474785

First Posted

November 15, 2011

Last Updated

May 18, 2018

Sponsor

Vanderbilt University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01474785

Brief Title

RYGB and the Gastric Adipose Axis

Official Title

RYGB Improves Metabolism by Interrupting the Gastric Adipose Tissue Axis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Bariatric surgery, Nashville, Tennessee

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RYGB

Arm Type

Experimental

Arm Description

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

Arm Title

VSG

Arm Type

Experimental

Arm Description

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

Arm Title

Low Calorie Diet

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

human ghrelin

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

very low calorie diet

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Hyperinsulinemic/Euglycemic Clamp

Intervention Description

Insulin and glucose infusions to measure glucose kinetics.

Primary Outcome Measure Information:

Title

change in glucose disposal rate

Description

Glucose disposal rate is a sensitive laboratory procedure for determining how your body uses sugar (called insulin sensitivity).

Time Frame

baseline and 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naji Abumrad, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

34232

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35724307

Citation

Flynn CR, Tamboli RA, Antoun J, Sidani RM, Williams B, Spann MD, English WJ, Welch EB, Sundaresan S, Abumrad NN. Caloric Restriction and Weight Loss Are Primary Factors in the Early Tissue-Specific Metabolic Changes After Bariatric Surgery. Diabetes Care. 2022 Aug 1;45(8):1914-1916. doi: 10.2337/dc22-0069.

Results Reference

derived

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RYGB and the Gastric Adipose Axis

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