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Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes (Stampede II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01278823
First received: January 17, 2011
Last updated: July 30, 2014
Last verified: July 2014

January 17, 2011
July 30, 2014
January 2011
December 2014   (final data collection date for primary outcome measure)
Test the effect of gastric bypass surgery on glycemic control in obese type 2 DM patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01278823 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes
Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Type 2 Diabetes
  • Procedure: laparoscopic roux en y gastric bypass operation
    roux en y gastric bypass operation
    Other Name: bariatric surgery
  • Other: medical management
    latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen
    Other Names:
    • meal replacement
    • exercise
    • group support
  • Experimental: surgery
    laparoscopic roux en y gastric bypass
    Intervention: Procedure: laparoscopic roux en y gastric bypass operation
  • Active Comparator: Medical treatment
    Comprehensive medical management of diabetes including medications, diet intervention, lifestyle modification, exercise regimen
    Intervention: Other: medical management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01278823
1R01DK089547
Yes
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: John Kirwan, PhD The Cleveland Clinic
The Cleveland Clinic
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP