GU: Glucose Uptake in Metabolic Tissues After Bariatric Surgery

Sponsor

Washington University School of Medicine (Other)

Overall Status

Terminated

CT.gov ID

NCT03563885

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arms

8.5

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to provide a comprehensive evaluation of whole-body and tissue-specific glucose metabolism after consuming a mixed meal in lean people and people with obesity, before and after 20-35% weight loss induced by Roux-en-Y gastric bypass or sleeve gastrectomy surgery.

Condition or Disease	Intervention/Treatment	Phase
Obesity Insulin Resistance	Procedure: bariatric surgery	N/A

Detailed Description

Obesity is associated with an impairment in postprandial glucose disposal, which is an important risk factor for type 2 diabetes (T2D). Weight loss improves postprandial glycemic control. The difficulty in achieving successful weight loss by using lifestyle therapy (diet and physical activity) has led to an increased interest in bariatric surgery, which is the most effective available weight loss therapy. Moreover, bariatric surgery procedures that bypass the upper gastrointestinal tract, such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), have profound effects on glycemic control and cause remission in a large percentage of people with T2D. However, the effect of RYGB and SG surgery on postprandial glucose disposal among key metabolic organs has not been investigated and compared. The goal of this study is to provide a comprehensive evaluation of whole-body and tissue-specific glucose metabolism after consuming a mixed meal in lean people and people with obesity, before and after 20-35% weight loss induced by RYGB or SG surgery. Glucose uptake (GU) will be assessed by using: i) a combination of oral and intravenous stable isotopically-labeled glucose tracers to assess the delivery of ingested glucose into the systemic circulation and whole-body glucose disposal rate; and ii) positron emission tomography (PET) with magnetic resonance (MR) imaging to assess muscle, subcutaneous and visceral adipose tissue, liver, small intestine, and pancreas GU.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Effect of Bariatric Surgery on Tissue-specific Glucose Uptake

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Jun 18, 2019

Actual Study Completion Date :

Jun 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RYGB or SG Baseline testing followed by subject's already scheduled RYGB or SG surgery, and then post-testing.	Procedure: bariatric surgery subjects already scheduled Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery
No Intervention: Lean Lean control subjects doing baseline testing only.

Arm

Intervention/Treatment

Experimental: RYGB or SG

Baseline testing followed by subject's already scheduled RYGB or SG surgery, and then post-testing.

Procedure: bariatric surgery

subjects already scheduled Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery

No Intervention: Lean

Lean control subjects doing baseline testing only.

Outcome Measures

Primary Outcome Measures

Change in insulin sensitivity [An average of 6 months from baseline testing to 20-35% weight loss]
Insulin sensitivity will be assessed by positron emission topography & magnetic resonance imaging before and after bariatric surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

BMI 35.0-50.0 kg/m2 for obese group and 18.5-24.9 kg/m2 for the lean group
Must be scheduled for RYGB or SG surgery

Exclusion Criteria:

Previous bariatric surgery
Unstable weight (>4% change during the last 2 months before entering the study)
Significant organ system dysfunction (e.g., severe pulmonary or kidney disease)
Cancer or cancer that has been in remission for <5 years
Conditions that render subject unable to complete all testing procedures (e.g. metal implants that interfere with imaging procedures; coagulation disorders)
Use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study
Pregnant or lactating women
Persons who are not able to grant voluntary informed consent
Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Human Nutrition	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Washington University School of Medicine
National Institutes of Health (NIH)

Investigators

Principal Investigator: George Schweitzer, PhD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT03563885

Other Study ID Numbers:

304180015

First Posted:

Jun 20, 2018

Last Update Posted:

Jan 28, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Jan 28, 2020