Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus

Type II Diabetes Mellitus Clinical Trial

— T2DM  

Official title:

Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00540462
• Other study ID #: Diabetes01
• Status: Recruiting
• Phase: Phase 4
• First received: October 4, 2007
• Last updated: November 13, 2008
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: October 2008
• Source: Min-Sheng General Hospital
• Contact: Lee WeiJei, M.D, Ph.D
• Phone: 886-3-3179599
• Email: wjlee_obessurg_tw[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Although intensive medical treatment of diabetes has clearly been demonstrated to be worthwhile, it has not been a total success in diabetes treatment for a variety of reasons including lack of response to medication. Diabetes has been well demonstrated as a co-morbidity illness of obesity patients. In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base of this observation, we will try to find out the role surgical intervention (gastric bypass & sleeve gastrectomy) in obese-related diabetes.

Description:

In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base on this observation, we will try to find out the role surgical intervention (gastric bypass and sleeve gastrectomy) in obese-related diabetes. With restriction of stomach volume and with or without duodenal exclusion, this randomized trials will find out the role of duodenal exclusion and the role of Ghrenin in obese-related type II DM patients. The initial observation of previous morbidly obese patients with type II DM, the DM seems a chronic disease which could be treated or controlled by surgical intervention, that's what we try to know more.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient with diagnosis of T2DM for at least 6 months

• Mild to moderate obesity status(BMI 27 - 35 )

• Age : 30 - 60 year-old

• HbA1C > 8 %

Exclusion Criteria:

• With co-morbidity illness of cardiovascular system

• DM related nephropathy (Cre >2.0 mg/dl)

• Pulmonary embolism or uncontrolled coagulopathy in 6 months

• HBV or HCV hepatitis or liver cirrhosis, inflammatory colon disease, Cushing syndrome

• s/p organ transplantation

• Previously Bariatric surgery, gastrointestinal surgery, or abdominal sepsis

• Alcoholic or drug abuser

• Psychological disease.

• HIV or TB patient

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes Mellitus

Intervention

Procedure:
• gastric bypass

• sleeve gastrectomy

Locations

Country	Name	City	State
Taiwan	MinSheng Genral Hospital	Taoyuan

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	Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.		1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months	Yes
Secondary	Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy		1 yr	Yes