Clinical trial NCT01989988: DMBSS-A Randomized Trial of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
Official title: A Randomized Trial Study of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus Type 2 in Obese
Keywords: Type 2 Diabetes Mellitus (T2DM)
Obesity
Laparoscopic gastric bypass
Duodenum exclusion
Lead sponsor: Min-Sheng General Hospital
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Remission of diabetes
timeFrame: two years
Secondary outcomes:
measure: weight loss and improvement in quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Min-Sheng General Hospital
Study officials:
affiliation: Min-Sheng General Hospital
name: Wei-Jei Lee, M.D., PH.D
role: STUDY_CHAIR
References: