Atherosclerotic Cardiovascular DiseasePhase 2/3EURDSSNCT01353066
Gastric Bypass Versus Best Medical Treatment on Progression of Carotid-intima Media Thickness in Type 2 Diabetes Mellitus (T2DM)
A Phase 2/3 study testing Intensive Medical Treatment and IMM+Roux-en-Y Gastric Bypass (RYGBP) in people with Atherosclerotic Cardiovascular Disease and Subclinical Disease and/or Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial intervention in T2DM associated with obesity. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Subclinical Disease and/or Syndrome
- What is being tested?
- Intensive Medical Treatment and IMM+Roux-en-Y Gastric Bypass (RYGBP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 35 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Age 35 to 65 years at eligibility visit.
- Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least he six months prior to enrollment, and HbA 1c > 7.0 %.
- Current treatment for T2DM consisting of multiple doses of insulin with/without hypoglycemic agents or hypoglycemic agents plus basal insulin.
- Optimization of diabetes medical treatment prior to inclusion in the study would have been performed based on best medical practices.
- Body Mass Index (BMI)> 30.0 kg/m2 and <34.9 kg/m2 at eligibility visit.
- Willingness to accept random assignment to either treatment group.
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- Expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial.
- Willingness to comply with the follow-up protocol and successful completion of the run-in.
- 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 (grade II or IV), angina pectoris, symptomatic peripheral vascular disease or advanced cardiovascular disease.
- History of severe hypoglycemic episodes associated with medical treatment of type 2 DM
- 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.
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- Significant anemia or history of coagulopathy.
- Serum creatinine >1.5 mg/dl.
- Serum total bilirubin or alkaline phosphatase greater than the upper limit of normal, or ALT greater than twice the upper limit of normal.
- History of previous surgery contraindicating gastric bypass at the criteria of the surgical team.
- Gastric or duodenal ulcer in the past six months.
- History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
- Previous organ transplantation.
- Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
- Currently pregnant or nursing, or planning to become pregnant in the next two years.
- History of alcohol or drug dependency (excluding caffeine and nicotine) in the past five years
- Active psychosocial or psychiatric problem that is likely to interferer with adherence to the protocol.
- Score of 17 or higher on the CES-D (depression scale).
- Current participation in a conflicting research protocol.
- Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
- 12-lead EKG indicating that surgery or intensive medical treatment would not be safe.
- Diagnosed with diabetes more than 15 years ago.
- Positive GAD antibodies
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Josep Vidal, MD
About this study
Official title: Multicenter Randomized Prospective Trial on the Effects of Intensive Medical Treatment of Type 2 Diabetes With and Without Roux-in-Y Gastric Bypass Surgery on Carotid Intima Media Thickness in Grade I Obesity (BMI 30,0-34,9 kg/m2)
Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at the control of CVRF in T2DM may not translate in the reduction of CV events.
Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) could be superior in the control of the progression of subclinical atherosclerotic disease, as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9 kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients
- Being tested
- Intensive Medical Treatment, IMM+Roux-en-Y Gastric Bypass (RYGBP)
- Keywords
- Type 2 Diabetes Mellitus, BMI 30.0-34.9 kg/m2
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Medical TreatmentDrug
IMM+Roux-en-Y Gastric Bypass (RYGBP)Other
| Study group | Role | What they receive |
|---|---|---|
| Intensive Medical Treatment | Active comparator | Not described Receives: Drug: Intensive Medical Treatment |
| Intensive medical treatment (IMM)+RYGBP | Experimental | Not described Receives: Other: IMM+Roux-en-Y Gastric Bypass (RYGBP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the progression carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353066
- Sponsor's protocol ID
- HCB-UOM-012011
- Acronym
- EURDSS
- Status last verified
- May 2011
- First submitted
- 11 May 2011
- Last updated
- 12 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Prospective Trial on the Effects of Intensive Medical Treatment of Type 2 Diabetes With and Without Roux-in-Y Gastric Bypass Surgery on Carotid Intima Media Thickness in Grade I Obesity (BMI 30,0-34,9 kg/m2)
- ClinicalTrials.gov ID
- NCT01353066
- Acronym / sponsor ID
- EURDSS / HCB-UOM-012011
- Keywords
- Type 2 Diabetes Mellitus, BMI 30.0-34.9 kg/m2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- First posted
- 12 May 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.
Background: Type 2 Diabetes Mellitus (T2DM) is associated with an increased burden for cardiovascular disease (CVD). Multifactorial interventions are necessary to reduce the CV risk in T2DM. Bariatric surgery appears to be an alternative for the multifactorial intervention in T2DM associated with obesity. Data have shown, that clinical trial aiming at the control of CVRF in T2DM may not translate in the reduction of CV events.
Hypothesis: Intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) could be superior in the control of the progression of subclinical atherosclerotic disease, as evaluated by carotid ultrasound, in subjects with T2DM and a BMI between 30.0 and 34.9 kg/m2.The primary aim of the study is To compare the effects of intensive medical treatment (IMM) including Roux-en-Y Gastric Bypass (RYGBP) and IMM alone on the progression of the carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline.Methodology: Two-year Randomized Clinical Trial, including 240 patients
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Medical Treatment | Active comparator | Drug: Intensive Medical Treatment |
| Intensive medical treatment (IMM)+RYGBP | Experimental | Other: IMM+Roux-en-Y Gastric Bypass (RYGBP) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 35 to 65 years at eligibility visit.
- Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least he six months prior to enrollment, and HbA 1c > 7.0 %.
- Current treatment for T2DM consisting of multiple doses of insulin with/without hypoglycemic agents or hypoglycemic agents plus basal insulin.
- Optimization of diabetes medical treatment prior to inclusion in the study would have been performed based on best medical practices.
- Body Mass Index (BMI)> 30.0 kg/m2 and <34.9 kg/m2 at eligibility visit.
Key exclusion criteria (23 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 (grade II or IV), angina pectoris, symptomatic peripheral vascular disease or advanced cardiovascular disease.
- History of severe hypoglycemic episodes associated with medical treatment of type 2 DM
- Cardiac stress test indicating that surgery would not be safe
- Pulmonary embolus or thrombophlebitis in the past six months.
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 |
|---|---|---|
| Intensive Medical Treatment | Drug | Intensive Medical Treatment |
| IMM+Roux-en-Y Gastric Bypass (RYGBP) | Other | Intensive medical treatment (IMM)+RYGBP |
Primary outcome
Measurement of the progression carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intensive Medical Treatment and IMM+Roux-en-Y Gastric Bypass (RYGBP) in people with Atherosclerotic Cardiovascular Disease and Subclinical Disease and/or Syndrome, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 9 inclusion and 23 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 12 May 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 Spain. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Antonio M Lacy, MD (+34932279854, steres@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the progression carotid intima media thickness (CIMT) at 24 months after entry into the trial relative to baseline (time frame: 24 months). 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 12 May 2011.