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Glucose Uptake in Metabolic Tissues After Bariatric Surgery (GU)

Primary Purpose

Obesity, Insulin Resistance

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bariatric surgery
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RYGB or SG

Lean

Arm Description

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

Lean control subjects doing baseline testing only.

Outcomes

Primary Outcome Measures

Change in insulin sensitivity
Insulin sensitivity will be assessed by positron emission topography & magnetic resonance imaging before and after bariatric surgery

Secondary Outcome Measures

Full Information

First Posted
June 8, 2018
Last Updated
January 23, 2020
Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03563885
Brief Title
Glucose Uptake in Metabolic Tissues After Bariatric Surgery
Acronym
GU
Official Title
Effect of Bariatric Surgery on Tissue-specific Glucose Uptake
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Financial and Method issues suggesting that study is not feasible.
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 18, 2019 (Actual)
Study Completion Date
June 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RYGB or SG
Arm Type
Experimental
Arm Description
Baseline testing followed by subject's already scheduled RYGB or SG surgery, and then post-testing.
Arm Title
Lean
Arm Type
No Intervention
Arm Description
Lean control subjects doing baseline testing only.
Intervention Type
Procedure
Intervention Name(s)
bariatric surgery
Intervention Description
subjects already scheduled Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery
Primary Outcome Measure Information:
Title
Change in insulin sensitivity
Description
Insulin sensitivity will be assessed by positron emission topography & magnetic resonance imaging before and after bariatric surgery
Time Frame
An average of 6 months from baseline testing to 20-35% weight loss

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Schweitzer, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Human Nutrition
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Glucose Uptake in Metabolic Tissues After Bariatric Surgery

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