Diabetes Mellitus Type 2 in ObeseDMBSSNCT01989988
DMBSS-A Randomized Trial of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
A study testing LMGB, LRYGB and SADJB in people with Diabetes Mellitus Type 2 in Obese, run by Min-Sheng General Hospital at 1 site in Taiwan.
Trial summary
The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2 Read more about this study
- Who is it for?
- Ages 20 to 67 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese
- What is being tested?
- LMGB, LRYGB and SADJB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2015
- Phase
- Interventional
- 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 20 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 to 67 years
- Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c ≥ 7.5 %
- Body Mass Index (BMI) ≥ 27.5 kg/m 2 and ≤ 34.9 kg/m 2
- Willingness to accept random assignment to either treatment group.
- Willingness to comply with the follow-up protocol
- Written informed consent.
Who cannot join
- Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- Cardiac stress test indicating that surgery would not be safe.
- Pulmonary embolus or thrombophlebitis in the past six months
- Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years
- Serum creatinine ≥ 1.5 mg/dl
Show all 10Show fewer
- History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection
- Previous organ transplantation.
- History of alcohol or drug dependency
- Current participation in a conflicting research protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Study of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2
Read the detailed description
The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2. This program will determine the relative effectiveness among LMGB 、RYGB and SADJB .The primary end point including HbA1C<6.0%, LDL-C<100mg/dl and SBP<130mmHg at one year after surgery. Through this study, the investigators may understand which gastric bypass is the best for type 2 diabetic's treatment. The investigators also hope some new treatment modulation may be developed.
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Being tested
- LMGB, LRYGB, SADJB
- Keywords
- Type 2 Diabetes Mellitus (T2DM), Obesity, Laparoscopic gastric bypass, Duodenum exclusion
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMGBProcedure or surgery
LRYGBProcedure or surgery
SADJBProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| LRYGB | Active comparator | 20 subjects Randomized will undergo LRYGB surgery Receives: Procedure: LRYGB |
| SADJB | Active comparator | 20 subjects will undergo SADJB surgery Receives: Procedure: SADJB |
| LMGB | Active comparator | 20 subjects will undergo LMGB surgery Receives: Procedure: LMGB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of diabetes
remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery
Measured: two years
Secondary outcomes (1)
weight loss and improvement in quality of life
weight loss and improvements in quality of life after different types of gastric bypass surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Sheng General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WEI-CHENG YAO, Min-Sheng General Hospital
- Investigators
- Wei-Jei Lee, M.D., PH.D, Study chair, Min-Sheng General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989988
- Sponsor's protocol ID
- MSIRB2013003
- Other IDs
- MSIRB2013003
- Acronym
- DMBSS
- Status last verified
- Nov 2013
- First submitted
- 22 Jan 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Study of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
- ClinicalTrials.gov ID
- NCT01989988
- Acronym / sponsor ID
- DMBSS / MSIRB2013003
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Keywords
- Type 2 Diabetes Mellitus (T2DM), Obesity, Laparoscopic gastric bypass, Duodenum exclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Min-Sheng General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Nov 2013 (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.
The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2
Detailed description
The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2. This program will determine the relative effectiveness among LMGB 、RYGB and SADJB .The primary end point including HbA1C<6.0%, LDL-C<100mg/dl and SBP<130mmHg at one year after surgery. Through this study, the investigators may understand which gastric bypass is the best for type 2 diabetic's treatment. The investigators also hope some new treatment modulation may be developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LRYGB | Active comparator | Procedure: LRYGB20 subjects Randomized will undergo LRYGB surgery |
| SADJB | Active comparator | Procedure: SADJB20 subjects will undergo SADJB surgery |
| LMGB | Active comparator | Procedure: LMGB20 subjects will undergo LMGB surgery |
Who may qualify
- Ages
- 20 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 20 to 67 years
- Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c ≥ 7.5 %
- Body Mass Index (BMI) ≥ 27.5 kg/m 2 and ≤ 34.9 kg/m 2
- Willingness to accept random assignment to either treatment group.
- Willingness to comply with the follow-up protocol
Key exclusion criteria (10 listed)
- Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- Cardiac stress test indicating that surgery would not be safe.
- Pulmonary embolus or thrombophlebitis in the past six months
- Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years
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 |
|---|---|---|
| LMGB | Procedure or surgery | LMGB |
| LRYGB | Procedure or surgery | LRYGB |
| SADJB | Procedure or surgery | SADJB |
Primary outcome
Remission of diabetes
Time frame: two years
remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery
1 secondary outcome
weight loss and improvement in quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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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.
Wei-Jei Lee, M.D., PH.D study chair
Min-Sheng General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMGB, LRYGB and SADJB in people with Diabetes Mellitus Type 2 in Obese, 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 6 inclusion and 10 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 21 Nov 2013. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of diabetes (time frame: two years). 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 21 Nov 2013.