- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02166372
Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery (TDS)
T2DM has become a major health burden for our society. More and more data support the relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI over 27.5 in Asia.
The evidence reviewed above strongly points to the need for a large randomized, controlled trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2 diabetes Mellitus. This study is expected to provide very significant findings about the natural course of diabetes in obese diabetic patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Wei-Lei Lee, PhD
- Phone Number: 1615 88633179599
- Email: wjlee_obessurg_tw@yahoo.com.tw
Study Locations
-
-
-
Taoyuan City, Taiwan, 33044
- Recruiting
- Min-Sheng General Hospital
-
Contact:
- Wei-Jei Lee, PhD
- Phone Number: 1615 88633179599
- Email: wjlee_obessurg_tw@yahoo.com.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diabetic Mellitus Type 2 medically controlled at Diabetes Center for at least six months
- BMI over 25
- age between 20 and 67
Exclusion Criteria:
- Diagnosed with cancer within past five years
- HIV positive
- Active TB patients
- CV events in past six months
- serum cretinine over 2.0 mg/dl
- C-peptide bellow 1.0 ng/ml in past three months
- Diabetic retinopathy; vision bellow 0.1
- Cushing's syndrome
- History of organ transplant
- History of bariatric surgery
- History of alcohol or drug dependency in past five years
- Psychological problems likely to interfere with adherence to protocol
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obese diabetic patients
Diabetic patients with BMI over 25 Age 20 to 67 Diabetes medically controlled at our center for at least six months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate the natural course of the diabetes of obese patients over a period of 10 years
Time Frame: ten years
|
ten years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wei-Jei Lee, MD PhD, Min-Sheng General Hospital; National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MSIRB2014009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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