Comparison of diabetes outcomes in mildly obese patients undergoing metabolic surgery
Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery
This study looks at how metabolic surgery affects diabetes management in mildly obese people with type 2 diabetes over ten years compared to those who don’t have the surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 20 Years to 67 Years |
| Sex | All |
| Sponsor | Min-Sheng General Hospital Academic / other |
| Locations | 1 site (Taoyuan City) |
| Trial ID | NCT02166372 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 1,000 obese patients with type 2 diabetes mellitus (T2DM) across Taiwan, focusing on those with a BMI over 25 and who have been under medical management for at least six months. The study will evaluate the natural course of diabetes over a 10-year period, assessing primary outcomes such as HbA1c levels, LDL cholesterol, and blood pressure annually after intervention. By comparing outcomes in patients who undergo metabolic surgery with those who do not, the study seeks to provide significant insights into the effectiveness of bariatric surgery in managing T2DM.
Who should consider this trial
Good fit: Ideal candidates for this study are obese individuals aged 20 to 67 with medically controlled T2DM for more than six months and a BMI over 25.
Not a fit: Patients with recent cancer diagnoses, HIV, active tuberculosis, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable evidence on the long-term benefits of metabolic surgery for managing type 2 diabetes in mildly obese patients.
How similar studies have performed: Other studies have indicated the potential effectiveness of metabolic surgery in managing T2DM, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taoyuan City
- Min-Sheng General Hospital — Taoyuan City, Taiwan (Recruiting)
Study contacts
- Principal investigator: Wei-Jei Lee, MD PhD — Min-Sheng General Hospital; National Taiwan University Hospital
- Study coordinator: Wei-Lei Lee, PhD
- Email: wjlee_obessurg_tw@yahoo.com.tw
- Phone: 88633179599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.