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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Min-Sheng General Hospital

March 2, 2011
March 18, 2011
March 18, 2011
January 2011
March 2012   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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Asian Diabetes Surgery Study (ADSS): Clinical Predictor for the Success of Metabolic Surgery
Asian Diabetes Surgery Study:A Multi-institutes Prospective Study Clinical Predictor for the Successful Treatment of Type 2 Diabetes After Metabolic Surgery
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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Serum stored at a -85 ℃ refrigerator
Probability Sample
  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
  • Disease
  • Endocrine System Disease
  • Diabetes Mellitus
Not Provided
Diabetes group I
metabolic surgery, laparoscopicly
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Same as current
December 2013
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01317979
MSIRB2011003
Yes
Not Provided
Not Provided
Min-Sheng General Hospital IRB
Min-Sheng General Hospital
Not Provided
Principal Investigator: Jun Juin Tsou, university Metabolic surgery center,Minsheng general hospital
Min-Sheng General Hospital
March 2011