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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery|
- Evaluate the natural course of the diabetes of obese patients over a period of 10 years [ Time Frame: ten years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||December 2034|
|Estimated Primary Completion Date:||December 2024 (Final data collection date for primary outcome measure)|
Obese diabetic patients
Diabetic patients with BMI over 25 Age 20 to 67 Diabetes medically controlled at our center for at least six months
|Other: Observation of natural course of Diabetes Mellitus Type 2|
This study will recruit 200 obese T2DM patients at MSGH, for a total of 1000 in Taiwan. The inclusion criteria are those with T2DM more than 6 months, under medical management in diabetes center, BMI over 25, age between 20 and 67 years. The goals of this study are to evaluate the nature course of the diabetes for 10 years. The primary outcomes for the treatment will be assessed every year after intervention and will be composite of CVD risk factor; specifically, the proportion of patients with HbA1c < 7%, LDL cholesterol < 100 mg/dl and systolic blood pressure < 140 mmHg.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02166372
|Contact: Wei-Lei Lee, PhD||88633179599 ext firstname.lastname@example.org|
|Min-Sheng General Hospital||Recruiting|
|Taoyuan City, Taiwan, 33044|
|Contact: Wei-Jei Lee, PhD 88633179599 ext 1615 email@example.com|
|Principal Investigator:||Wei-Jei Lee, MD PhD||Min-Sheng General Hospital; National Taiwan University Hospital|