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

NCT ID: NCT01317979

Last Updated: 2011-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-12-31

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.

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.

Conditions

Disease; Endocrine System Disease; Diabetes Mellitus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetes group I

metabolic surgery, laparoscopicly

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Min-Sheng General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Min-Sheng General Hospital IRB

Principal Investigators

Jun Juin Tsou, university

Role: PRINCIPAL_INVESTIGATOR

Metabolic surgery center,Minsheng general hospital

Locations

Min sheng general hospital

Taoyuan, , Taiwan

Site Status: RECRUITING

MinSheng Genral Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

JunJuin Tsou

Role: CONTACT

ms3164297@yahoo.com.tw

+88633179599 ext. 8320

Reiwan Kauo

Role: CONTACT

p001335@e-ms.com.tw

+88633179599 ext. 2052

Facility Contacts

Lee WeiJei, M.D, Ph.D

Role: primary

wjlee_obessurg_tw@yahoo.com.tw

886-3-3179599 ext. 1599

Other Identifiers

MSIRB2011003

Identifier Type: -

Identifier Source: org_study_id