Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus (T2DM)
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ClinicalTrials.gov Identifier: NCT00540462 |
Recruitment Status
: Unknown
Verified October 2008 by Min-Sheng General Hospital.
Recruitment status was: Recruiting
First Posted
: October 8, 2007
Last Update Posted
: November 14, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type II Diabetes Mellitus | Procedure: gastric bypass Procedure: sleeve gastrectomy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus |
Study Start Date : | August 2007 |
Estimated Primary Completion Date : | August 2008 |
Estimated Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
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 |
- Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months ]
- Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy [ Time Frame: 1 yr ]

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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540462
Contact: Lee WeiJei, M.D, Ph.D | 886-3-3179599 ext 1599 | wjlee_obessurg_tw@yahoo.com.tw |
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 |
Principal Investigator: | Lee WeiJei, M.D, Ph.D | MSGH |
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 |
First Posted: | October 8, 2007 Key Record Dates |
Last Update Posted: | November 14, 2008 |
Last Verified: | October 2008 |
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 |