Overview

This trial is active, not recruiting.

Condition diabetes mellitus type 2 in obese
Treatments lmgb, lrygb, sadjb
Sponsor Min-Sheng General Hospital
Start date January 2013
End date July 2015
Trial size 60 participants
Trial identifier NCT01989988, MSIRB2013003

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
20 subjects Randomized will undergo LRYGB surgery
lrygb
(Active Comparator)
20 subjects will undergo SADJB surgery
sadjb
(Active Comparator)
20 subjects will undergo LMGB surgery
lmgb

Primary Outcomes

Measure
Remission of diabetes
time frame: two years

Secondary Outcomes

Measure
weight loss and improvement in quality of life
time frame: 2 years

Eligibility Criteria

Male or female participants from 20 years up to 67 years old.

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.

Additional Information

Official title A Randomized Trial Study of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Min-Sheng General Hospital.