DiabetesTDSNCT02166372
Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery
An observational study of Diabetes, run by Min-Sheng General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Observation of natural course of Diabetes Mellitus Type 2
- How many people
- 1,000 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Dec 2034
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diabetic patients in Taiwan
Who may be able to join
- Diabetic Mellitus Type 2 medically controlled at Diabetes Center for at least six months
- BMI over 25
- age between 20 and 67
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Min-Sheng General Hospital
Taoyuan City, 33044
Wei-Jei Lee, PhD, 88633179599 ext. 1615, wjlee_obessurg_tw@yahoo.com.tw
About this study
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.
Read the detailed 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.
- Conditions
- Diabetes
- Being tested
- Observation of natural course of Diabetes Mellitus Type 2
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of natural course of Diabetes Mellitus Type 2Other
| Study group | Role | What they receive |
|---|---|---|
| Obese diabetic patients | Diabetic patients with BMI over 25 Age 20 to 67 Diabetes medically controlled at our center for at least six months Receives: Other: Observation of natural course of Diabetes Mellitus Type 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the natural course of the diabetes of obese patients over a period of 10 years
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Sheng General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI-CHENG YAO, Min-Sheng General Hospital
- Investigators
- Wei-Jei Lee, MD PhD, Principal investigator, Min-Sheng General Hospital; National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166372
- Sponsor's protocol ID
- MSIRB2014009
- Acronym
- TDS
- Status last verified
- Jun 2014
- First submitted
- 16 Jun 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes