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

Diabetes Mellitus Type 2 in Obese Clinical Trial

— DMBSS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01989988
• Other study ID #: MSIRB2013003
• Secondary ID: MSIRB2013003
• Status: Active, not recruiting
• Phase: N/A
• First received: January 22, 2013
• Last updated: November 15, 2013
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2013
• Source: Min-Sheng General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 67 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 in Obese
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• LMGB

• LRYGB

• SADJB

Locations

Country	Name	City	State
Taiwan	Min-Sheng General Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Min-Sheng General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of diabetes	remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery	two years	Yes
Secondary	weight loss and improvement in quality of life	weight loss and improvements in quality of life after different types of gastric bypass surgery	2 years	No