Efficacy and Safety Study of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) to Treat Type 2 Diabetes Mellitus (ADSMT-1)
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Purpose
Type 2 diabetes mellitus (T2DM) resolution in morbidly obese patients following bariatric surgery suggests the efficacy of metabolic surgery in non-morbidly obese patients (body mass index [BMI]<35 kg/m2). Many researches have shown available evidence about the efficacy and safety of metabolic surgery for resolution of T2DM in the non-morbidly obese. One of the most effective metabolic surgeries is laparoscopic Roux-en-Y gastric bypass (LRYGB). The investigators intend to run a 3 year prospective multicenter study to evaluate the remission efficacy of laparoscopic Roux-en-Y gastric bypass in Type 2 Diabetes mellitus with low BMI (BMI:25-35) in Asia area.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus - Poor Control |
Procedure: Laparoscopic Roux en Y gastric Bypass |
Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Efficacy and Safety Study of LRYGB to Treat Type 2 Diabetes Mellitus |
- 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) ] [ Designated as safety issue: Yes ]
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
Biospecimen Retention: Samples Without DNA
Blood and urine
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Procedure: 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
Other Name: LRYGB
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
500 type 2 diabetes mellitus patients with BMI between 25-35 kg/m2
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.
Contacts and Locations| Contact: Chih-Kun Huang, Doctor | +886-7-6150011 ext 5266 | dr.ckhuang@hotmail.com |
| Taiwan | |
| BMI Surgery Center, E-DA Hospital | Not yet recruiting |
| Kaohsiung, Taiwan, 824 | |
| Contact: Chih-Kun Huang, Doctor +886-7-6150011 ext 5266 dr.ckhuang@hotmail.com | |
| Principal Investigator: | Chih-Kun Huang, Doctor | E-DA Hospital |
More Information
No publications provided
| Responsible Party: | Dr. Huang, Chih-Kun, Bariatric & Metabolic International Surgery Center |
| ClinicalTrials.gov Identifier: | NCT01277900 History of Changes |
| Other Study ID Numbers: | ADSMT-1 |
| Study First Received: | January 11, 2011 |
| Last Updated: | January 14, 2011 |
| Health Authority: | Taiwan: Department of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013