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Efficacy and Safety Study of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) to Treat Type 2 Diabetes Mellitus (ADSMT-1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Asia Metabolic Surgery Research Group.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
E-DA Hospital
Information provided by:
Asia Metabolic Surgery Research Group
ClinicalTrials.gov Identifier:
NCT01277900
First received: January 11, 2011
Last updated: January 14, 2011
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by Asia Metabolic Surgery Research Group:

Primary Outcome Measures:
  • 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
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277900

Contacts
Contact: Chih-Kun Huang, Doctor +886-7-6150011 ext 5266 dr.ckhuang@hotmail.com

Locations
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   
Sponsors and Collaborators
Asia Metabolic Surgery Research Group
E-DA Hospital
Investigators
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014