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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus - Poor Control
• Intervention / Treatment: Procedure: Laparoscopic Roux en Y gastric Bypass

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: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 824
    • BMI Surgery Center, E-DA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

500 type 2 diabetes mellitus patients with BMI between 25-35 kg/m2

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

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	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 Names: LRYGB

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	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)

Collaborators and Investigators

• Sponsor: Asia Metabolic Surgery Research Group
• Collaborators: E-DA Hospital
• Investigators: Principal Investigator: Chih-Kun Huang, Doctor, E-Da Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: January 11, 2011
• First Submitted That Met QC Criteria: January 14, 2011
• First Posted (Estimate): January 17, 2011

Study Record Updates

• Last Update Posted (Estimate): January 17, 2011
• Last Update Submitted That Met QC Criteria: January 14, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ADSMT-1