Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus (T2DM)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Min-Sheng General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Min-Sheng General Hospital
Information provided by:
Min-Sheng General Hospital
ClinicalTrials.gov Identifier:
NCT00540462
First received: October 4, 2007
Last updated: November 13, 2008
Last verified: October 2008
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus |
Resource links provided by NLM:
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 |
|---|---|
|
No Intervention: 1
Medical Group
|
|
|
Active Comparator: 2
Surgical Group with gastric bypass
|
Procedure: gastric bypass |
|
Active Comparator: 3
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 (Adult) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00540462
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Min-Sheng General Hospital |
| ClinicalTrials.gov Identifier: | NCT00540462 History of Changes |
| Other Study ID Numbers: | Diabetes01 |
| Study First Received: | October 4, 2007 |
| Last Updated: | November 13, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016