Text Size

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

This study is currently recruiting participants.
Verified March 2011 by Min-Sheng General Hospital
Sponsor:
Information provided by:
Min-Sheng General Hospital
ClinicalTrials.gov Identifier:
NCT01317979
First received: March 2, 2011
Last updated: March 17, 2011
Last verified: March 2011
History of Changes
  Purpose

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
Disease
Endocrine System Disease
Diabetes Mellitus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Biospecimen Retention:   Samples With DNA

Serum stored at a -85 ℃ refrigerator


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes group I
metabolic surgery, laparoscopicly

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317979

Contacts
Contact: JunJuin Tsou +88633179599 ext 8320 ms3164297@yahoo.com.tw
Contact: Reiwan Kauo +88633179599 ext 2052 p001335@e-ms.com.tw

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

No publications provided

Responsible Party: Min-Sheng General Hospital IRB
ClinicalTrials.gov Identifier: NCT01317979     History of Changes
Other Study ID Numbers: MSIRB2011003
Study First Received: March 2, 2011
Last Updated: March 17, 2011
Health Authority: Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013