Type 2 Diabetes Mellitus - Poor Control Clinical Trial
— ADSMT-1Official title:
Efficacy and Safety Study of LRYGB to Treat Type 2 Diabetes Mellitus
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 2013 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 60 Years |
Eligibility |
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; 4. Uncontrolled psychiatric disease; 5. 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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Taiwan | BMI Surgery Center, E-DA Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Asia Metabolic Surgery Research Group | E-DA Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastric Bypass in the Treatment of Type 2 Diabetes in Patients with a BMI of 25 to 35 kg/m2 | 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) | Yes |