Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus - Full Text View

Sponsored by:	Min-Sheng General Hospital
Information provided by:	Min-Sheng General Hospital
ClinicalTrials.gov Identifier:	NCT00540462

Purpose

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.

Condition	Intervention	Phase
Type II Diabetes Mellitus	Procedure: gastric bypass Procedure: sleeve gastrectomy	Phase IV

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus

Further study details as provided by Min-Sheng General Hospital:

Primary Outcome Measures:

Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Medical Group
2: Active Comparator Surgical Group with gastric bypass	Procedure: gastric bypass
3: Active Comparator Sugical Group with Sleeve gastrectomy	Procedure: sleeve gastrectomy

Detailed 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.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540462

Contacts

Contact: Lee WeiJei, M.D, Ph.D

886-3-3179599 ext 1599

wjlee_obessurg_tw@yahoo.com.tw

Locations

Taiwan
MinSheng Genral Hospital	Recruiting
Taoyuan, Taiwan
Contact: Lee WeiJei, M.D, Ph.D 886-3-3179599 ext 1599 wjlee_obessurg_tw@yahoo.com.tw

Sponsors and Collaborators

Min-Sheng General Hospital

Investigators

Principal Investigator:

Lee WeiJei, M.D, Ph.D

MSGH

More Information

Responsible Party:	Min-Sheng General Hospital ( Min-Sheng General Hospital )
Study ID Numbers:	Diabetes01
Study First Received:	October 4, 2007
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00540462
Health Authority:	Taiwan: Department of Health; Taiwan: Institutional Review Board

Keywords provided by Min-Sheng General Hospital:

Type II Diabetes Mellitus
Gastric bypass
Obese-related diabetes mellitus
Sugar control
treatment of obesity related diabetes mellitus

Study placed in the following topic categories:

Obesity
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 14, 2009