Type 2 Diabetes Mellitus - Poor ControlADSMT-1NCT01277900
Efficacy and Safety Study of Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) to Treat Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus - Poor Control, run by Asia Metabolic Surgery Research Group at 1 site in Taiwan.
Trial summary
Type 2 diabetes mellitus (T2DM) resolution in morbidly obese patients following bariatric surgery suggests the efficacy of metabolic surgery in non-morbidly obese patients (body mass index [BMI]<35 kg/m2). Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus - Poor Control
- What is being tested?
- Laparoscopic Roux en Y gastric Bypass
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 500 type 2 diabetes mellitus patients with BMI between 25-35 kg/m2
Who may be able to join
- T2DM diagnosed over 1 year;
- Age ranged 30-60 years;
- BMI 25-35 kg/m2;
- Patient consent and will to receive long-term follow up and periodic check up.
Who cannot join
- T1DM;
- Substance abuse;
- Planned pregnancy within 2 year after surgery;
- Uncontrolled psychiatric disease;
- Lost follow up.
- Institutions inclusion criteria: Professional experience over 30 LRYGB performed.
- Trial termination criteria: Surgical mortality over 0.5% in the first year, and Diabetes remission rate failure over 20% in one year.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
BMI Surgery Center, E-DA Hospital
Kaohsiung, Taiwan, 824
Chih-Kun Huang, Doctor, +886-7-6150011 ext. 5266, dr.ckhuang@hotmail.com
About this study
Official title: Efficacy and Safety Study of LRYGB to Treat Type 2 Diabetes Mellitus
Type 2 diabetes mellitus (T2DM) resolution in morbidly obese patients following bariatric surgery suggests the efficacy of metabolic surgery in non-morbidly obese patients (body mass index [BMI]<35 kg/m2). Many researches have shown available evidence about the efficacy and safety of metabolic surgery for resolution of T2DM in the non-morbidly obese. One of the most effective metabolic surgeries is laparoscopic Roux-en-Y gastric bypass (LRYGB). The investigators intend to run a 3 year prospective multicenter study to evaluate the remission efficacy of laparoscopic Roux-en-Y gastric bypass in Type 2 Diabetes mellitus with low BMI (BMI:25-35) in Asia area.
Read the detailed description
The study is designed including 9 bariatric centers across Asia region( China, Korea, Phillipine, Singapore and Taiwan). Totally 500 patients with confirmed diagnosis of T2DM and BMI between 25-35 kg/m2 will be enrolled from January 2011 to December 2013. Preoperative surgical parameters, blood, biochemistry data, gastrointestinal hormones, upper gastrointestinal studies, abdominal ultrasound, peri-operative \& postoperative complications will all be recorded and analyzed. Patient inclusion criteria: 1.) T2DM diagnosed over 1 year; 2.) age ranged 30-60 years; 3.) BMI 25-35 kg/m2; 4.) Patient consent and will to receive long-term follow up and periodic check up. Exclusion criteria: 1.) T1DM; 2.) Substance abuse; 3.) Planned pregnancy within 2 year after surgery; 3.) Uncontrolled psychiatric disease; 4.) Lost follow up. Institutions inclusion criteria: Professional experience over 30 LRYGB performed. Trial termination criteria: Surgical mortality over 0.5% in the first year, and Diabetes remission rate failure over 20% in one year.
All data will be collected yearly in one center. The analysis of parameter, statistics and brief results will be informed to enrolled institutions periodically.
- Conditions
- Type 2 Diabetes Mellitus - Poor Control
- Being tested
- Laparoscopic Roux en Y gastric Bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Roux en Y gastric BypassProcedure or surgery
Also called LRYGB
Laparoscopic Roux-en-Y gastric bypass will be used as a standard procedure to treat type 2 diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass | Laparoscopic Roux-en-Y gastric bypass will be used as a standard procedure to treat type 2 diabetes mellitus Receives: Procedure: Laparoscopic Roux en Y gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Bypass in the Treatment of Type 2 Diabetes in Patients with a BMI of 25 to 35 kg/m2
An observational, prospective and multi-center study will be carry out with IRB approval. A total of 500 type 2 diabetes mellitus patients with low BMI (25-35 kg/m2) will be collected in different surgical institutions. Pre and post operative biochemical parameters will be collected at the 1st, 6th, 12th, 24th and 36th months. Comparative outcomes will support the relationship between diabetes improvement or remission and the surgical intervention.
Blood parameters: CBC, hs-CRP, SMA12, HbA1c, Fasting C-peptide, Insulin, OGTT,C-peptide and DM antibodies
Measured: 3 years (from 2011 to 2013)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 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 Type 2 Diabetes Mellitus - Poor ControlStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asia Metabolic Surgery Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- E-DA Hospital
- Investigators
- Chih-Kun Huang, Doctor, Principal investigator, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277900
- Sponsor's protocol ID
- ADSMT-1
- Acronym
- ADSMT-1
- Status last verified
- Jan 2011
- First submitted
- 11 Jan 2011
- Last updated
- 17 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of LRYGB to Treat Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01277900
- Acronym / sponsor ID
- ADSMT-1 / ADSMT-1
- Conditions
- Type 2 Diabetes Mellitus - Poor Control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Asia Metabolic Surgery Research GroupUniversity, hospital or other
- Collaborators
- E-DA Hospital
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 Jan 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) resolution in morbidly obese patients following bariatric surgery suggests the efficacy of metabolic surgery in non-morbidly obese patients (body mass index [BMI]<35 kg/m2). Many researches have shown available evidence about the efficacy and safety of metabolic surgery for resolution of T2DM in the non-morbidly obese. One of the most effective metabolic surgeries is laparoscopic Roux-en-Y gastric bypass (LRYGB). The investigators intend to run a 3 year prospective multicenter study to evaluate the remission efficacy of laparoscopic Roux-en-Y gastric bypass in Type 2 Diabetes mellitus with low BMI (BMI:25-35) in Asia area.
Detailed description
The study is designed including 9 bariatric centers across Asia region( China, Korea, Phillipine, Singapore and Taiwan). Totally 500 patients with confirmed diagnosis of T2DM and BMI between 25-35 kg/m2 will be enrolled from January 2011 to December 2013. Preoperative surgical parameters, blood, biochemistry data, gastrointestinal hormones, upper gastrointestinal studies, abdominal ultrasound, peri-operative \& postoperative complications will all be recorded and analyzed. Patient inclusion criteria: 1.) T2DM diagnosed over 1 year; 2.) age ranged 30-60 years; 3.) BMI 25-35 kg/m2; 4.) Patient consent and will to receive long-term follow up and periodic check up. Exclusion criteria: 1.) T1DM; 2.) Substance abuse; 3.) Planned pregnancy within 2 year after surgery; 3.) Uncontrolled psychiatric disease; 4.) Lost follow up. Institutions inclusion criteria: Professional experience over 30 LRYGB performed. Trial termination criteria: Surgical mortality over 0.5% in the first year, and Diabetes remission rate failure over 20% in one year.
All data will be collected yearly in one center. The analysis of parameter, statistics and brief results will be informed to enrolled institutions periodically.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Roux-en-Y gastric bypass | – | Procedure: Laparoscopic Roux en Y gastric BypassLaparoscopic Roux-en-Y gastric bypass will be used as a standard procedure to treat type 2 diabetes mellitus |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 500 type 2 diabetes mellitus patients with BMI between 25-35 kg/m2
Key inclusion criteria (4 listed)
- T2DM diagnosed over 1 year;
- Age ranged 30-60 years;
- BMI 25-35 kg/m2;
- Patient consent and will to receive long-term follow up and periodic check up.
Key exclusion criteria (7 listed)
- T1DM;
- Substance abuse;
- Planned pregnancy within 2 year after surgery;
- Uncontrolled psychiatric disease;
- Lost follow up.
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 |
|---|---|---|
| Laparoscopic Roux en Y gastric BypassAlso: LRYGBLaparoscopic Roux-en-Y gastric bypass will be used as a standard procedure to treat type 2 diabetes mellitus | Procedure or surgery | Laparoscopic Roux-en-Y gastric bypass |
Primary outcome
Gastric Bypass in the Treatment of Type 2 Diabetes in Patients with a BMI of 25 to 35 kg/m2
Time frame: 3 years (from 2011 to 2013)
An observational, prospective and multi-center study will be carry out with IRB approval. A total of 500 type 2 diabetes mellitus patients with low BMI (25-35 kg/m2) will be collected in different surgical institutions. Pre and post operative biochemical parameters will be collected at the 1st, 6th, 12th, 24th and 36th months. Comparative outcomes will support the relationship between diabetes improvement or remission and the surgical intervention. Blood parameters: CBC, hs-CRP, SMA12, HbA1c, Fasting C-peptide, Insulin, OGTT,C-peptide and DM antibodies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 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.
Chih-Kun Huang, Doctor principal investigator
E-DA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus - Poor Control, run by Asia Metabolic Surgery Research Group 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 7 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 17 Jan 2011. 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.
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 Chih-Kun Huang, Doctor (+886-7-6150011 ext. 5266, dr.ckhuang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Bypass in the Treatment of Type 2 Diabetes in Patients with a BMI of 25 to 35 kg/m2 (time frame: 3 years (from 2011 to 2013)). It is what the study was designed to measure, not a finding.
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 17 Jan 2011.