Efficacy and Safety Study of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) to Treat Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus - Poor Control Clinical Trial

— ADSMT-1  

Official title:

Efficacy and Safety Study of LRYGB to Treat Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01277900
• Other study ID #: ADSMT-1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 11, 2011
• Last updated: January 14, 2011
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2011
• Source: Asia Metabolic Surgery Research Group
• Contact: Chih-Kun Huang, Doctor
• Phone: +886-7-6150011
• Email: dr.ckhuang[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus - Poor Control

Intervention

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

Locations

Country	Name	City	State
Taiwan	BMI Surgery Center, E-DA Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Asia Metabolic Surgery Research Group	E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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