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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Min-Sheng General Hospital
Sponsor:
Information provided by (Responsible Party):
WEI-CHENG YAO, Min-Sheng General Hospital
ClinicalTrials.gov Identifier:
NCT02166372
First received: June 16, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes
Other: Observation of natural course of Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery

Resource links provided by NLM:


Further study details as provided by Min-Sheng General Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
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)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Diabetic patients in Taiwan

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02166372

Contacts
Contact: Wei-Lei Lee, PhD 88633179599 ext 1615 wjlee_obessurg_tw@yahoo.com.tw

Locations
Taiwan
Min-Sheng General Hospital Recruiting
Taoyuan City, Taiwan, 33044
Contact: Wei-Jei Lee, PhD    88633179599 ext 1615    wjlee_obessurg_tw@yahoo.com.tw   
Sponsors and Collaborators
Min-Sheng General Hospital
Investigators
Principal Investigator: Wei-Jei Lee, MD PhD Min-Sheng General Hospital; National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: WEI-CHENG YAO, Professor, Min-Sheng General Hospital
ClinicalTrials.gov Identifier: NCT02166372     History of Changes
Other Study ID Numbers: MSIRB2014009
Study First Received: June 16, 2014
Last Updated: June 16, 2014
Health Authority: Taiwan: Ministry of Health and Welfare

ClinicalTrials.gov processed this record on September 18, 2014