Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ethicon Endo-Surgery
LifeScan
Information provided by (Responsible Party):
Philip Schauer, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00432809
First received: February 6, 2007
Last updated: December 20, 2013
Last verified: December 2013
Results First Received: November 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
Obesity
Interventions: Procedure: Gastric bypass
Procedure: Sleeve Gastrectomy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study recruitment began December 2006 and the last patient was enrolled January 2011. Patients were recruited from the Bariatric and Diabetes Outpatient clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
68 patients screened fail prior to randomization due to not meeting inclusion criteria.

Reporting Groups
  Description
Medical Therapy Intensive medical therapy for diabetes
Gastric Bypass Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
Sleeve Gastrectomy Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy

Participant Flow for 2 periods

Period 1:   1 Year Follow-up
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
STARTED     50     50     50  
COMPLETED     41     50     49  
NOT COMPLETED     9     0     1  
Misses 9 and 12 month visit                 2                 0                 0  
Withdrawal by Subject                 7                 0                 1  

Period 2:   2 Year Sub-study
    Medical Therapy     Gastric Bypass     Sleeve Gastrectomy  
STARTED     20     20     20  
COMPLETED     17     18     19  
NOT COMPLETED     3     2     1  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6%.   [ Time Frame: 1 year ]

2.  Primary:   Success Rate of Biochemical Resolution of Diabetes at 12 Months as Measured by HbA1c ≤ 6% With no Diabetes Medications   [ Time Frame: 1 year ]

3.  Secondary:   Change in Glycated Hemoglobin (HbA1c)   [ Time Frame: 1 year - baseline ]

4.  Secondary:   Fasting Plasma Glucose   [ Time Frame: 1 year ]

5.  Secondary:   Glycated Hemoglobin (HbA1c)   [ Time Frame: 1 year ]

6.  Secondary:   Body Weight   [ Time Frame: 1 year ]

7.  Secondary:   Change in Body Weight From Baseline   [ Time Frame: 1 year ]

8.  Secondary:   Body Mass Index (BMI)   [ Time Frame: 1 year ]

9.  Secondary:   Change in Body Mass Index (BMI)   [ Time Frame: 1 year ]

10.  Secondary:   Change in Systolic Blood Pressure (SBP)   [ Time Frame: 1 year ]

11.  Secondary:   Change in High-density Lipoprotein (HDL)   [ Time Frame: 1 year ]

12.  Secondary:   Change in Triglycerides   [ Time Frame: 1 year ]

13.  Secondary:   Change in High-sensitivity C-reactive Protein (Hs-CRP)   [ Time Frame: 1 year ]

14.  Secondary:   Diabetes Medication - Use of Insulin   [ Time Frame: 1 year ]

15.  Secondary:   Diabetes Medication - Use of Biguanides   [ Time Frame: 1 year ]

16.  Secondary:   Diabetes Medication - Use of Thiazolidinedione   [ Time Frame: 1 year ]

17.  Secondary:   Diabetes Medication - Use of Incretin Mimetics   [ Time Frame: 1 year ]

18.  Secondary:   Diabetes Medication - Use of Secretagogue   [ Time Frame: 1 year ]

19.  Secondary:   Cardiovascular Medications - Lipid Lowering Agents   [ Time Frame: 1 year ]

20.  Secondary:   Cardiovascular Medications - Beta Blocker   [ Time Frame: 1 year ]

21.  Secondary:   Cardiovascular Medications - Angiotensin-converting Enzyme (ACE Inhibitor) or Angiotensin-receptor Blocker (ARB)   [ Time Frame: 1 year ]

22.  Secondary:   Cardiovascular Medications - Anticoagulants   [ Time Frame: 1 year ]

23.  Secondary:   Changes in Specific Metabolic Parameters (Insulin Secretion and Resistance).   [ Time Frame: 1, 2, and 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

24.  Secondary:   Changes in Obesity-related Comorbidities (Blood Pressure, Dyslipidemia), Quality of Life, and Hospitalizations.   [ Time Frame: 1, 2, and 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

25.  Secondary:   The Cost-effectiveness of Each Program and the Side Effects and /or Complications.   [ Time Frame: 1, 2, and 5 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Important limitations in the primary endpoint and 1 year outcomes are the short duration of follow-up (12 months), the study occurred at a single-center and the open-label nature of the study (subjects were not blinded to treatment).


  More Information