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

NCT01277900 | Unknown DMC

• 1 other identifier: ADSMT-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus - Poor Control

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

Laparoscopic Roux en Y gastric Bypass PROCEDURE

Laparoscopic Roux-en-Y gastric bypass will be used as a standard procedure to treat type 2 diabetes mellitus

Also known as: LRYGB

Laparoscopic Roux-en-Y gastric bypass

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• T1DM;
• Substance abuse;
• Planned pregnancy within 2 year after surgery;
• Uncontrolled psychiatric disease;
• Lost follow up.
• Trial termination criteria: Surgical mortality over 0.5% in the first year, and Diabetes remission rate failure over 20% in one year.

Sponsors & Collaborators

• Asia Metabolic Surgery Research Group: lead
• E-DA Hospital: collaborator

Study Sites (1)

BMI Surgery Center, E-DA Hospital

Kaohsiung, Taiwan, 824, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine

Study Officials

• Chih-Kun Huang, Doctor

  E-DA Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Kun Huang, Doctor

CONTACT

+886-7-6150011; dr.ckhuang@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2011
• First Posted: January 17, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: December 1, 2013
• Last Updated: January 17, 2011

Record last verified: 2011-01

Locations

TW (1)