DMBSS-A Randomized Trial of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM (DMBSS)

November 15, 2013 updated by: WEI-CHENG YAO, Min-Sheng General Hospital

A Randomized Trial Study of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM

The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2. This program will determine the relative effectiveness among LMGB 、RYGB and SADJB .The primary end point including HbA1C<6.0%, LDL-C<100mg/dl and SBP<130mmHg at one year after surgery. Through this study, the investigators may understand which gastric bypass is the best for type 2 diabetic's treatment. The investigators also hope some new treatment modulation may be developed.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan, 330
        • Min-Sheng General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20 to 67 years
  • Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c ≥ 7.5 %
  • Body Mass Index (BMI) ≥ 27.5 kg/m 2 and ≤ 34.9 kg/m 2
  • Willingness to accept random assignment to either treatment group.
  • Willingness to comply with the follow-up protocol
  • Written informed consent.

Exclusion Criteria:

  • Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
  • Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
  • Cardiac stress test indicating that surgery would not be safe.
  • Pulmonary embolus or thrombophlebitis in the past six months
  • Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years
  • Serum creatinine ≥ 1.5 mg/dl
  • History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection
  • Previous organ transplantation.
  • History of alcohol or drug dependency
  • Current participation in a conflicting research protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: LRYGB
20 subjects Randomized will undergo LRYGB surgery
Procedure: LRYGB
Active Comparator: SADJB
20 subjects will undergo SADJB surgery
Procedure: SADJB
Active Comparator: LMGB
20 subjects will undergo LMGB surgery
Procedure: LMGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of diabetes
Time Frame: two years
remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss and improvement in quality of life
Time Frame: 2 years
weight loss and improvements in quality of life after different types of gastric bypass surgery
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Min-Sheng General Hospital

Investigators

  • Study Chair: Wei-Jei Lee, M.D., PH.D, Min-Sheng General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

November 15, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSIRB2013003 (Other Identifier: MSIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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