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Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes (RBD-T2D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207777
Recruitment Status : Active, not recruiting
First Posted : August 4, 2014
Last Update Posted : April 12, 2022
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
For this purpose, we will compare the effects of targeted 16-18% (with a range of 16-25%) weight loss induced by Roux-en-Y Gastric bypass (RYGB) surgery with the same weight loss induced by a low-calorie diet (LCD) on liver and skeletal muscle insulin sensitivity, beta-cell function, and 24-hour metabolic homeostasis in obese subjects with or without T2D.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Procedure: Roux-en-Y gastric bypass surgery Behavioral: Low-calorie diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
Actual Study Start Date : August 2014
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Roux-en-Y gastric bypass (RYGB)
Subjects in this group are scheduled to undergo roux-en-Y gastric bypass surgery to obtain approximately 16-18% (with a range of 16-25%) weight loss.
Procedure: Roux-en-Y gastric bypass surgery
A surgical procedure to help subjects lose approximately 16-18% (with a range of 16-25%) of their body weight.

Active Comparator: Low-calorie diet
Subjects in this group will participate in a low-calorie diet intervention to obtain approximately 16-18% (with a range of 16-25%) weight loss.
Behavioral: Low-calorie diet
Subjects will meet with a dietitian and/or behaviorist over approximately 6 months to lose approximately 16-18% (with a range of 16-25%) of their body weight.




Primary Outcome Measures :
  1. Changes in hepatic insulin sensitivity [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.


Secondary Outcome Measures :
  1. Changes in skeletal muscle and adipose tissue insulin sensitivity [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.

  2. Changes in Beta-cell function [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be assessed as the product of beta-cell glucose sensitivity (ratio of post-meal insulin secretion rate to post-meal plasma glucose) during mixed-meal test and whole-body insulin sensitivity before and after weight loss.

  3. Changes in glucose kinetics (glucose concentration and rate of appearance into the systemic circulation) in response to mixed-meal ingestion [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be measured by using dual glucose tracer mixed meal metabolic test and serial blood sampling for 4 hours before and after weight loss

  4. Changes in 24-hour plasma glucose profile [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be determined by obtaining serial plasma glucose concentration measurements for 24 hours before and after weight loss

  5. Changes in 24-hour plasma insulin profile [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will determined by obtaining serial plasma insulin concentration measurements for 24 hours before and after weight loss

  6. Changes in 24-hour plasma free fatty acid profile [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will determined by obtaining serial plasma free fatty acid concentration measurements for 24 hours before and after weight loss

  7. Changes in body fat mass [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss

  8. Changes in intra-abdominal adipose tissue volume [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be measured by using magnetic resonance imaging before and after weight loss

  9. Changes in intrahepatic triglyceride content [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be measured by using magnetic resonance imaging before and after weight loss

  10. Changes in fat free mass [ Time Frame: 6 months (before and after targeted weight loss) ]
    The outcome will be measured by using dual-energy X-ray absorptiometry before and after weight loss



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For RYGB group:

  • Scheduled for this bariatric surgery
  • Body Mass Index (BMI) 34-55 kg/m²
  • Type 2 Diabetes
  • Signed informed consent

For Low-Calorie Diet group:

  • BMI 34-55 kg/m²
  • Type 2 Diabetes and Non-Diabetics
  • Signed informed consent

Exclusion Criteria:

For both RYGB & Low-Calorie Diet groups

  • Regular use of tobacco products
  • Previous intestinal resection
  • Pregnant or breastfeeding
  • Evidence of significant organ system dysfunction or disease other than T2D
  • Use of any medication that might, in the opinion of the investigator, affect metabolic function
  • Exercise ≥90 minutes per week

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): NCT02207777


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Samuel Klein, MD Washington University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02207777    
Other Study ID Numbers: 201403065
1R01DK101578 ( U.S. NIH Grant/Contract )
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
Obesity
Roux-en-Y gastric bypass (RYGB)
Type 2 Diabetes
Weight Loss
Low-Calorie Diet
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Body Weight Changes