DMBSS-A Randomized Trial of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
NCT ID: NCT01989988
Last Updated: 2013-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2013-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LRYGB
20 subjects Randomized will undergo LRYGB surgery
LRYGB
SADJB
20 subjects will undergo SADJB surgery
SADJB
LMGB
20 subjects will undergo LMGB surgery
LMGB
Interventions
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LMGB
LRYGB
SADJB
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
67 Years
ALL
No
Sponsors
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Min-Sheng General Hospital
OTHER
Responsible Party
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WEI-CHENG YAO
Department of Surgery
Principal Investigators
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Wei-Jei Lee, M.D., PH.D
Role: STUDY_CHAIR
Min-Sheng General Hospital
Locations
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Min-Sheng General Hospital
Taoyuan, , Taiwan
Countries
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Other Identifiers
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MSIRB2013003
Identifier Type: OTHER
Identifier Source: secondary_id
MSIRB2013003
Identifier Type: -
Identifier Source: org_study_id