Type II Diabetes MellitusPhase 4T2DMNCT00540462
Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
A Phase 4 study testing gastric bypass and sleeve gastrectomy in people with Type II Diabetes Mellitus, run by Min-Sheng General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- gastric bypass and sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 %
Who cannot join
- 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
Show all 9Show fewer
- Alcoholic or drug abuser
- Psychological disease.
- HIV or TB patient
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
MinSheng Genral Hospital
Taoyuan
Lee WeiJei, M.D, Ph.D, 886-3-3179599 ext. 1599, wjlee_obessurg_tw@yahoo.com.tw
About this study
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.
Read the 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.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- gastric bypass, sleeve gastrectomy
- Keywords
- Type II Diabetes Mellitus, Gastric bypass, Obese-related diabetes mellitus, Sugar control, treatment of obesity related diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric bypassProcedure or surgery
sleeve gastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Medical Group |
| 2 | Active comparator | Surgical Group with gastric bypass Receives: Procedure: gastric bypass |
| 3 | Active comparator | Sugical Group with Sleeve gastrectomy Receives: Procedure: sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.
Measured: 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
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Sheng General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Lee WeiJei, M.D, Ph.D, Principal investigator, MSGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540462
- Sponsor's protocol ID
- Diabetes01
- Acronym
- T2DM
- Status last verified
- Oct 2008
- First submitted
- 4 Oct 2007
- Last updated
- 14 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21339423
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00540462
- Acronym / sponsor ID
- T2DM / Diabetes01
- Conditions
- Type II Diabetes Mellitus
- Keywords
- Type II Diabetes Mellitus, Gastric bypass, Obese-related diabetes mellitus, Sugar control, treatment of obesity related diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Min-Sheng General HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Medical Group |
| 2 | Active comparator | Procedure: gastric bypassSurgical Group with gastric bypass |
| 3 | Active comparator | Procedure: sleeve gastrectomySugical Group with Sleeve gastrectomy |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 %
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric bypass | Procedure or surgery | 2 |
| sleeve gastrectomy | Procedure or surgery | 3 |
Primary outcome
Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months
1 secondary outcome
Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy
Time frame: 1 yr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2008.
- Derived from this study: PubMed 21339423Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee WeiJei, M.D, Ph.D principal investigator
MSGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gastric bypass and sleeve gastrectomy in people with Type II Diabetes Mellitus, run by Min-Sheng General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee WeiJei, M.D, Ph.D (886-3-3179599 ext. 1599, wjlee_obessurg_tw@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT. (time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540462, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2008.