Asian Diabetes Surgery Study (ADSS): Clinical Predictor for the Success of Metabolic Surgery (ADSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01317979
Recruitment Status : Unknown
Verified March 2011 by Min-Sheng General Hospital.
Recruitment status was:  Recruiting
First Posted : March 18, 2011
Last Update Posted : March 18, 2011
Information provided by:
Min-Sheng General Hospital

Brief Summary:
Type 2 Diabetes Mellitus (T2DM) is a serious health problem that has increased dramatically worldwide due to the high and increasing prevalence of obesity. Medical management of T2DM is of limited success. Because not well controlled T2DM patients are in high risk of blindness, cardiovascular accident and end staged disease, T2DM has become a major health burden for society. Recent data on the relative effectiveness of gastrointestinal metabolic surgery played as bariatric surgery in the remission of T2DM, suggests that it may be significantly more effective than current medical treatment. In considering that less than half of the T2DM patients can achieve satisfactory treatment goal under current medical treatment, gastrointestinal metabolic surgery shall play an important role in T2DM treatment in the future. However, the indication for metabolic surgery and clinical predictors of success are not clear now. These clinical predictors can help us to choose appropriate not-well controlled T2DM patients to receive metabolic surgery and reduce dverse health outcomes in those patients.

Condition or disease
Disease Endocrine System Disease Diabetes Mellitus

Detailed Description:
The present research proposal is designed to assess the clinical predictors of success in T2DM patients who receive metabolic surgery for the treatment of their diabetes. This study will recruit 200 obese T2DM patients who receive gastrointestinal metabolic surgery in our center and follow up them for one year. The Inclusion criteria are those with T2DM more than 6 months, age between 18 to 65 and HbA1C > 8%. All the pre-operative clinical parameters will be collected prospectively, including C-peptide and stimulated C-peptide. The genetic polymorphism of these patients will also be analyzed and collected. The success of T2DM remission will be assessed at 12 months after metabolic surgery will be composite endpoint of CVD risk factor resolution; specifically, the proportion of patients with HbA1c < 6.5%. The clinical predictors will be analyzed by uni-vriate and muti-variate analysis. In the first year project, we will included 100 patients and will include another 100 patients at the second year. This project will apply for the budget of 1st year.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Asian Diabetes Surgery Study:A Multi-institutes Prospective Study Clinical Predictor for the Successful Treatment of Type 2 Diabetes After Metabolic Surgery
Study Start Date : January 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Diabetes group I
metabolic surgery, laparoscopicly

Biospecimen Retention:   Samples With DNA
Serum stored at a -85 ℃ refrigerator

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. Age between 18 to 65.
  2. Type 2 DM > 6 months, HbA1C>7.0% under treatment
  3. Body mass index >25 kg/m2
  4. could follow up

Inclusion Criteria:

  • Age between 18 to 65.
  • Type 2 DM > 6 months, HbA1C>8.0% under treatment
  • Body mass index >25 kg/m2
  • could follow up

Exclusion Criteria:

  • Age <18 or >65
  • HbA1C < 7%
  • BMI < 25 kg/m2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01317979

Contact: JunJuin Tsou +88633179599 ext 8320
Contact: Reiwan Kauo +88633179599 ext 2052

Min sheng general hospital Recruiting
Taoyuan city, Taiwan
MinSheng Genral Hospital Recruiting
Taoyuan, Taiwan
Contact: Lee WeiJei, M.D, Ph.D    886-3-3179599 ext 1599   
Sponsors and Collaborators
Min-Sheng General Hospital
Principal Investigator: Jun Juin Tsou, university Metabolic surgery center,Minsheng general hospital

Responsible Party: Min-Sheng General Hospital IRB Identifier: NCT01317979     History of Changes
Other Study ID Numbers: MSIRB2011003
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: March 18, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases