Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
T2DM
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 14, 2008
October 1, 2008
1 year
October 4, 2007
November 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.
1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months
Secondary Outcomes (1)
Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy
1 yr
Study Arms (3)
1
NO INTERVENTIONMedical Group
2
ACTIVE COMPARATORSurgical Group with gastric bypass
3
ACTIVE COMPARATORSugical Group with Sleeve gastrectomy
Interventions
Eligibility Criteria
You may qualify if:
- 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 %
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
MinSheng Genral Hospital
Taoyuan District, Taiwan
Related Publications (1)
Lee WJ, Chong K, Ser KH, Lee YC, Chen SC, Chen JC, Tsai MH, Chuang LM. Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. Arch Surg. 2011 Feb;146(2):143-8. doi: 10.1001/archsurg.2010.326.
PMID: 21339423DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lee WeiJei, M.D, Ph.D
MSGH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 8, 2007
Study Start
August 1, 2007
Primary Completion
August 1, 2008
Study Completion
December 1, 2008
Last Updated
November 14, 2008
Record last verified: 2008-10