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Glucose Uptake in Metabolic Tissues After Bariatric Surgery (GU)

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ClinicalTrials.gov Identifier: NCT03563885
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Washington University School of Medicine

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change in insulin sensitivity [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563885


Contacts
Contact: George Schweitzer, PhD 3142217957 george.schweitzer@wustl.edu

Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: George Schweitzer, PhD Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03563885     History of Changes
Other Study ID Numbers: 304180015
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases