- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00540462
Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus (T2DM)
November 13, 2008 updated by: Min-Sheng General Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lee WeiJei, M.D, Ph.D
- Phone Number: 1599 886-3-3179599
- Email: wjlee_obessurg_tw@yahoo.com.tw
Study Locations
-
-
-
Taoyuan, Taiwan
- Recruiting
- MinSheng Genral Hospital
-
Contact:
- Lee WeiJei, M.D, Ph.D
- Phone Number: 1599 886-3-3179599
- Email: wjlee_obessurg_tw@yahoo.com.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
Medical Group
|
|
Active Comparator: 2
Surgical Group with gastric bypass
|
|
Active Comparator: 3
Sugical Group with Sleeve gastrectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.
Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months
|
1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy
Time Frame: 1 yr
|
1 yr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lee WeiJei, M.D, Ph.D, MSGH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Anticipated)
August 1, 2008
Study Completion (Anticipated)
December 1, 2008
Study Registration Dates
First Submitted
October 4, 2007
First Submitted That Met QC Criteria
October 5, 2007
First Posted (Estimate)
October 8, 2007
Study Record Updates
Last Update Posted (Estimate)
November 14, 2008
Last Update Submitted That Met QC Criteria
November 13, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Diabetes01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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