Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery
TDS
1 other identifier
observational
1,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 16, 2014
CompletedFirst Posted
Study publicly available on registry
June 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2034
ExpectedJune 18, 2014
June 1, 2014
10.8 years
June 16, 2014
June 16, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the natural course of the diabetes of obese patients over a period of 10 years
ten years
Study Arms (1)
Obese diabetic patients
Diabetic patients with BMI over 25 Age 20 to 67 Diabetes medically controlled at our center for at least six months
Interventions
Eligibility Criteria
Diabetic patients in Taiwan
You may qualify if:
- Diabetic Mellitus Type 2 medically controlled at Diabetes Center for at least six months
- BMI over 25
- age between 20 and 67
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Min-Sheng General Hospital
Taoyuan, 33044, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei-Jei Lee, MD PhD
Min-Sheng General Hospital; National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 16, 2014
First Posted
June 18, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2024
Study Completion (Estimated)
December 1, 2034
Last Updated
June 18, 2014
Record last verified: 2014-06