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
  Purpose

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 Intervention
Obesity
Type 2 Diabetes
Procedure: laparoscopic roux en y gastric bypass operation
Other: medical management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: surgery
laparoscopic roux en y gastric bypass
Procedure: laparoscopic roux en y gastric bypass operation
roux en y gastric bypass operation
Other Name: bariatric surgery
Active Comparator: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01278823     History of Changes
Other Study ID Numbers: 1R01DK089547
Study First Received: January 17, 2011
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
obesity
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014