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

Primary Purpose

Diabetes Mellitus Type 2 in Obese

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
LMGB
LRYGB
SADJB
Sponsored by
Min-Sheng General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 in Obese focused on measuring Type 2 Diabetes Mellitus (T2DM), Obesity, Laparoscopic gastric bypass, Duodenum exclusion

Eligibility Criteria

20 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Min-Sheng General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

LRYGB

SADJB

LMGB

Arm Description

20 subjects Randomized will undergo LRYGB surgery

20 subjects will undergo SADJB surgery

20 subjects will undergo LMGB surgery

Outcomes

Primary Outcome Measures

Remission of diabetes
remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery

Secondary Outcome Measures

weight loss and improvement in quality of life
weight loss and improvements in quality of life after different types of gastric bypass surgery

Full Information

First Posted
January 22, 2013
Last Updated
November 15, 2013
Sponsor
Min-Sheng General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01989988
Brief Title
DMBSS-A Randomized Trial of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
Acronym
DMBSS
Official Title
A Randomized Trial Study of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Min-Sheng General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 in Obese
Keywords
Type 2 Diabetes Mellitus (T2DM), Obesity, Laparoscopic gastric bypass, Duodenum exclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LRYGB
Arm Type
Active Comparator
Arm Description
20 subjects Randomized will undergo LRYGB surgery
Arm Title
SADJB
Arm Type
Active Comparator
Arm Description
20 subjects will undergo SADJB surgery
Arm Title
LMGB
Arm Type
Active Comparator
Arm Description
20 subjects will undergo LMGB surgery
Intervention Type
Procedure
Intervention Name(s)
LMGB
Intervention Type
Procedure
Intervention Name(s)
LRYGB
Intervention Type
Procedure
Intervention Name(s)
SADJB
Primary Outcome Measure Information:
Title
Remission of diabetes
Description
remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery
Time Frame
two years
Secondary Outcome Measure Information:
Title
weight loss and improvement in quality of life
Description
weight loss and improvements in quality of life after different types of gastric bypass surgery
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Jei Lee, M.D., PH.D
Organizational Affiliation
Min-Sheng General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Min-Sheng General Hospital
City
Taoyuan City
ZIP/Postal Code
330
Country
Taiwan

12. IPD Sharing Statement

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

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