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Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes (STAMPEDEII)

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: NCT01278823
Recruitment Status : Active, not recruiting
First Posted : January 19, 2011
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes in men and women with a BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y gastric bypass operation or intensive medical, dietary and exercise management.

Condition or disease Intervention/treatment
Obesity Type 2 Diabetes Procedure: laparoscopic roux en y gastric bypass operation Other: medical management

Detailed Description:

Obesity and type 2 diabetes mellitus (T2DM) are two of the greatest public health problems of the 21st century. Lifestyle changes and pharmacotherapy, which are mainstay treatments for T2DM have had limited success. More intensive lifestyle weight management such as in the Look AHEAD trial reported an 8.6% weight loss after 1 year, while the Diabetes Prevention Program reported a 7% weight loss after 2 years, and a 58% decrease in the risk of developing T2DM. In contrast,we have observed a 31% weight loss together with 83% remission of T2DM in severely obese patients after Roux-en-Y gastric bypass (RYGB) surgery. However, direct evidence of the glycemic benefits of bariatric surgery from randomized control trials is lacking; there is no clear consensus that RYGB surgery is a good treatment option for moderately obese T2DM patients; and the mechanisms responsible for reversing T2DM after surgery remain unclear but may involve pancreatic insulin secretion and skeletal muscle and hepatic insulin resistance.

The objective of this application is to evaluate the effects of RYGB surgery on glycemic control and underlying mechanisms that contribute to T2DM in obese subjects (BMI: 30-40 kg/m2). Our central hypothesis is that RYGB surgery will reduce hyperglycemia via reversal of beta-cell dysfunction and decrease hepatic and peripheral insulin resistance. The approach requires a 12-month randomized controlled trial. The rationale is based on data showing that RYGB lowers fasting and postprandial glucose, and increases the GLP-1 response to a meal. However, the therapeutic efficacy of RYGB surgery in obesity-related T2DM needs to be demonstrated in a randomized trial.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes
Study Start Date : January 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: surgery
Surgery: laparoscopic roux en y gastric bypass operation
Procedure: laparoscopic roux en y gastric bypass operation
roux en y gastric bypass operation
Other Name: bariatric surgery
Active Comparator: Medical treatment
Medical Treatment: Comprehensive medical management of diabetes including medications, diet intervention, lifestyle modification, exercise regimen
Other: medical management
latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen
Other Names:
  • meal replacement
  • exercise
  • group support


Outcome Measures

Primary Outcome Measures :
  1. Test the effect of gastric bypass surgery on glycemic control in obese type 2 DM patients [ Time Frame: 12 months ]
    The working hypothesis for this aim is that significantly more obese T2DM patients who undergo RYGB surgery will achieve glycemic control based on a primary endpoint of an HbA1c ≤ 6.5% at 12 months, than patients managed by intensive medical therapy.


Secondary Outcome Measures :
  1. Determine the effects of gastric bypass surgery on pancreatic beta cell function and incretin hormone secretion in obese type 2 dm patients [ Time Frame: 12 months ]
    The working hypothesis for this aim is that a primary physiological link between obesity and T2DM is specific to beta-cell dysfunction; RYGB will reverse beta-cell dysfunction by increasing postprandial incretin secretion.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • candidate for general surgery
  • 18 to 60 years old
  • BMI 27-43
  • type 2 diabetes
  • willing to participate in either study arm
  • understand and comply with requirements of each arm
  • not pregnant
  • willing to use reliable birth control for duration of study

Exclusion Criteria:

  • prior bariatric surgery of any type
  • prior complex abdominal surgery
  • abdominal, thoracic, pelvic, obstetrical surgery within last 6 months
  • significant cardiovascular disease
  • kidney disease with a creatinine greater than or equal to 1.8 mg/dl
  • chronic liver disease except for NAFLD/NASH
  • celiac, malabsorptive, inflammatory bowel disorders
  • psychiatric disorders requiring 3 or more medications
  • pregnancy
  • cancer except squamous or basal cell skin cancer or cancer in remission
  • anticoagulation therapy that can't be stopped for surgery
  • clotting disorders
  • severe pulmonary disease
Contacts and Locations

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): NCT01278823


Locations
United States, Ohio
Cleveland Clinic Bariatric and Metabolic Institute, Department of Pathobiology
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: John Kirwan, PhD The Cleveland Clinic
More Information

Additional Information:
Responsible Party: John Kirwan, PhD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01278823     History of Changes
Other Study ID Numbers: 1R01DK089547 ( U.S. NIH Grant/Contract )
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John Kirwan, The Cleveland Clinic:
obesity
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases