DiseaseADSSNCT01317979
Asian Diabetes Surgery Study (ADSS): Clinical Predictor for the Success of Metabolic Surgery
An observational study of Disease and Endocrine System Disease, run by Min-Sheng General Hospital at 2 sites in Taiwan.
Trial summary
Type 2 Diabetes Mellitus (T2DM) is a serious health problem that has increased dramatically worldwide due to the high and increasing prevalence of obesity. Medical management of T2DM is of limited success. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disease, Endocrine System Disease, Diabetes Mellitus
- How many people
- 200 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Age between 18 to 65. 2. Type 2 DM > 6 months, HbA1C>7.0% under treatment 3. Body mass index >25 kg/m2 4. could follow up
Who may be able to join
- Age between 18 to 65.
- Type 2 DM > 6 months, HbA1C>8.0% under treatment
- Body mass index >25 kg/m2
- could follow up
Who cannot join
- Age <18 or >65
- HbA1C < 7%
- BMI < 25 kg/m2
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
MinSheng Genral Hospital
Taoyuan
Lee WeiJei, M.D, Ph.D, 886-3-3179599 ext. 1599, wjlee_obessurg_tw@yahoo.com.tw
- Recruiting
Min sheng general hospital
Taoyuan City
About this study
Official title: Asian Diabetes Surgery Study:A Multi-institutes Prospective Study Clinical Predictor for the Successful Treatment of Type 2 Diabetes After Metabolic Surgery
Type 2 Diabetes Mellitus (T2DM) is a serious health problem that has increased dramatically worldwide due to the high and increasing prevalence of obesity. Medical management of T2DM is of limited success. Because not well controlled T2DM patients are in high risk of blindness, cardiovascular accident and end staged disease, T2DM has become a major health burden for society. Recent data on the relative effectiveness of gastrointestinal metabolic surgery played as bariatric surgery in the remission of T2DM, suggests that it may be significantly more effective than current medical treatment. In considering that less than half of the T2DM patients can achieve satisfactory treatment goal under current medical treatment, gastrointestinal metabolic surgery shall play an important role in T2DM treatment in the future. However, the indication for metabolic surgery and clinical predictors of success are not clear now. These clinical predictors can help us to choose appropriate not-well controlled T2DM patients to receive metabolic surgery and reduce dverse health outcomes in those patients.
Read the detailed description
The present research proposal is designed to assess the clinical predictors of success in T2DM patients who receive metabolic surgery for the treatment of their diabetes. This study will recruit 200 obese T2DM patients who receive gastrointestinal metabolic surgery in our center and follow up them for one year. The Inclusion criteria are those with T2DM more than 6 months, age between 18 to 65 and HbA1C > 8%. All the pre-operative clinical parameters will be collected prospectively, including C-peptide and stimulated C-peptide. The genetic polymorphism of these patients will also be analyzed and collected. The success of T2DM remission will be assessed at 12 months after metabolic surgery will be composite endpoint of CVD risk factor resolution; specifically, the proportion of patients with HbA1c < 6.5%. The clinical predictors will be analyzed by uni-vriate and muti-variate analysis. In the first year project, we will included 100 patients and will include another 100 patients at the second year. This project will apply for the budget of 1st year.
- Conditions
- Disease, Endocrine System Disease, Diabetes Mellitus
- Medical subject headings
- Disease, Endocrine System Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes group I | metabolic surgery, laparoscopicly |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Sheng General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jun Juin Tsou, university, Principal investigator, Metabolic surgery center,Minsheng general hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317979
- Sponsor's protocol ID
- MSIRB2011003
- Acronym
- ADSS
- Status last verified
- Mar 2011
- First submitted
- 2 Mar 2011
- Last updated
- 18 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Diabetes Surgery Study:A Multi-institutes Prospective Study Clinical Predictor for the Successful Treatment of Type 2 Diabetes After Metabolic Surgery
- ClinicalTrials.gov ID
- NCT01317979
- Acronym / sponsor ID
- ADSS / MSIRB2011003
- Conditions
- Disease, Endocrine System Disease, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Min-Sheng General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Mar 2011 (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.
Type 2 Diabetes Mellitus (T2DM) is a serious health problem that has increased dramatically worldwide due to the high and increasing prevalence of obesity. Medical management of T2DM is of limited success. Because not well controlled T2DM patients are in high risk of blindness, cardiovascular accident and end staged disease, T2DM has become a major health burden for society. Recent data on the relative effectiveness of gastrointestinal metabolic surgery played as bariatric surgery in the remission of T2DM, suggests that it may be significantly more effective than current medical treatment. In considering that less than half of the T2DM patients can achieve satisfactory treatment goal under current medical treatment, gastrointestinal metabolic surgery shall play an important role in T2DM treatment in the future. However, the indication for metabolic surgery and clinical predictors of success are not clear now. These clinical predictors can help us to choose appropriate not-well controlled T2DM patients to receive metabolic surgery and reduce dverse health outcomes in those patients.
Detailed description
The present research proposal is designed to assess the clinical predictors of success in T2DM patients who receive metabolic surgery for the treatment of their diabetes. This study will recruit 200 obese T2DM patients who receive gastrointestinal metabolic surgery in our center and follow up them for one year. The Inclusion criteria are those with T2DM more than 6 months, age between 18 to 65 and HbA1C > 8%. All the pre-operative clinical parameters will be collected prospectively, including C-peptide and stimulated C-peptide. The genetic polymorphism of these patients will also be analyzed and collected. The success of T2DM remission will be assessed at 12 months after metabolic surgery will be composite endpoint of CVD risk factor resolution; specifically, the proportion of patients with HbA1c < 6.5%. The clinical predictors will be analyzed by uni-vriate and muti-variate analysis. In the first year project, we will included 100 patients and will include another 100 patients at the second year. This project will apply for the budget of 1st year.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes group I | – | –metabolic surgery, laparoscopicly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Age between 18 to 65. 2. Type 2 DM > 6 months, HbA1C>7.0% under treatment 3. Body mass index >25 kg/m2 4. could follow up
Key inclusion criteria (4 listed)
- Age between 18 to 65.
- Type 2 DM > 6 months, HbA1C>8.0% under treatment
- Body mass index >25 kg/m2
- could follow up
Key exclusion criteria (3 listed)
- Age <18 or >65
- HbA1C < 7%
- BMI < 25 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2011.
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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.
Jun Juin Tsou, university principal investigator
Metabolic surgery center,Minsheng general hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disease and Endocrine System Disease, run by Min-Sheng General Hospital at 2 sites 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 3 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 18 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 JunJuin Tsou (+88633179599 ext. 8320, ms3164297@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 18 Mar 2011.