- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01277900
Efficacy and Safety Study of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) to Treat Type 2 Diabetes Mellitus (ADSMT-1)
Efficacy and Safety Study of LRYGB to Treat Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is designed including 9 bariatric centers across Asia region( China, Korea, Phillipine, Singapore and Taiwan). Totally 500 patients with confirmed diagnosis of T2DM and BMI between 25-35 kg/m2 will be enrolled from January 2011 to December 2013. Preoperative surgical parameters, blood, biochemistry data, gastrointestinal hormones, upper gastrointestinal studies, abdominal ultrasound, peri-operative & postoperative complications will all be recorded and analyzed. Patient inclusion criteria: 1.) T2DM diagnosed over 1 year; 2.) age ranged 30-60 years; 3.) BMI 25-35 kg/m2; 4.) Patient consent and will to receive long-term follow up and periodic check up. Exclusion criteria: 1.) T1DM; 2.) Substance abuse; 3.) Planned pregnancy within 2 year after surgery; 3.) Uncontrolled psychiatric disease; 4.) Lost follow up. Institutions inclusion criteria: Professional experience over 30 LRYGB performed. Trial termination criteria: Surgical mortality over 0.5% in the first year, and Diabetes remission rate failure over 20% in one year.
All data will be collected yearly in one center. The analysis of parameter, statistics and brief results will be informed to enrolled institutions periodically.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Chih-Kun Huang, Doctor
- Phone Number: 5266 +886-7-6150011
- Email: dr.ckhuang@hotmail.com
Study Locations
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Kaohsiung, Taiwan, 824
- BMI Surgery Center, E-DA Hospital
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Contact:
- Chih-Kun Huang, Doctor
- Phone Number: 5266 +886-7-6150011
- Email: dr.ckhuang@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- T2DM diagnosed over 1 year;
- Age ranged 30-60 years;
- BMI 25-35 kg/m2;
- Patient consent and will to receive long-term follow up and periodic check up.
Exclusion Criteria:
- T1DM;
- Substance abuse;
- Planned pregnancy within 2 year after surgery;
- Uncontrolled psychiatric disease;
- Lost follow up.
Institutions inclusion criteria: Professional experience over 30 LRYGB performed.
Trial termination criteria: Surgical mortality over 0.5% in the first year, and Diabetes remission rate failure over 20% in one year.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Laparoscopic Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass will be used as a standard procedure to treat type 2 diabetes mellitus
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Laparoscopic Roux-en-Y gastric bypass will be used as a standard procedure to treat type 2 diabetes mellitus
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric Bypass in the Treatment of Type 2 Diabetes in Patients with a BMI of 25 to 35 kg/m2
Time Frame: 3 years (from 2011 to 2013)
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An observational, prospective and multi-center study will be carry out with IRB approval. A total of 500 type 2 diabetes mellitus patients with low BMI (25-35 kg/m2) will be collected in different surgical institutions. Pre and post operative biochemical parameters will be collected at the 1st, 6th, 12th, 24th and 36th months. Comparative outcomes will support the relationship between diabetes improvement or remission and the surgical intervention. Blood parameters: CBC, hs-CRP, SMA12, HbA1c, Fasting C-peptide, Insulin, OGTT,C-peptide and DM antibodies |
3 years (from 2011 to 2013)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chih-Kun Huang, Doctor, E-DA hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADSMT-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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