DMBSS-A Randomized Trial of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
DMBSS
A Randomized Trial Study of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 22, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 21, 2013
November 1, 2013
2.5 years
January 22, 2013
November 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission of diabetes
remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery
two years
Secondary Outcomes (1)
weight loss and improvement in quality of life
2 years
Study Arms (3)
LRYGB
ACTIVE COMPARATOR20 subjects Randomized will undergo LRYGB surgery
SADJB
ACTIVE COMPARATOR20 subjects will undergo SADJB surgery
LMGB
ACTIVE COMPARATOR20 subjects will undergo LMGB surgery
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Min-Sheng General Hospital
Taoyuan, 330, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wei-Jei Lee, M.D., PH.D
Min-Sheng General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Surgery
Study Record Dates
First Submitted
January 22, 2013
First Posted
November 21, 2013
Study Start
January 1, 2013
Primary Completion
July 1, 2015
Study Completion
December 1, 2015
Last Updated
November 21, 2013
Record last verified: 2013-11