Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery

Diabetes Clinical Trial

— TDS  

Official title:

Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02166372
• Other study ID #: MSIRB2014009
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2014
• Last updated: June 16, 2014
• Start date: March 2014
• Est. completion date: December 2034

Study information

• Verified date: June 2014
• Source: Min-Sheng General Hospital
• Contact: Wei-Lei Lee, PhD
• Phone: 88633179599
• Email: wjlee_obessurg_tw[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2034
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 67 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Observation of natural course of Diabetes Mellitus Type 2

Locations

Country	Name	City	State
Taiwan	Min-Sheng General Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Min-Sheng General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the natural course of the diabetes of obese patients over a period of 10 years		ten years	No