MEDINA: Metabolic syndrome, diabetes mellitus and renal protection
| ISRCTN | ISRCTN61411165 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61411165 |
| Secondary identifying numbers | LF2008/01, version 1.0, date: 22.06.2008 |
- Submission date
- 13/01/2010
- Registration date
- 27/05/2010
- Last edited
- 27/05/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jindøich pinar
Scientific
Scientific
Interní kardiologická klinika
Fakultní nemocnice Brno
Jihlavská 20
Brno
62500
Czech Republic
| Phone | +42 (0)53 2232601 |
|---|---|
| jspinar@fnbrno.cz |
Study information
| Study design | Multicentre open label randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | MEDINA: Metabolic syndrome, diabetes mellitus and renal protection: an open label, randomised, controlled, parallel group trial |
| Study acronym | MEDINA (metabolický syndrom, diabetes mellitus a nefroprotektivita) |
| Study objectives | The objective of this study is to find the optimal strategy of metabolic syndrome treatment, or diabetes mellitus and hypertension respectively. The basic questions are: 1. Does the treatment initiation with Angiotensin-Converting Enzyme Inhibitor have advantages over treatment initiation with Angiotensin II Antagonist ? 2. Which second drug should be used in combination? Diuretics or calcium antagonist? 3. How is the risk lowered by simultaneous administration of statin? |
| Ethics approval(s) | Multicentric Ethics Committee, University Hospital Brno Bohunice approved. |
| Health condition(s) or problem(s) studied | Metabolic syndrome; diabetes mellitus; hypertension |
| Intervention | Patients randomised to receive: 1. Angiotensin II Antagonist (Angiotensin receptor blocker [ARB]) 1.1. Baseline visit: Patients with blood pressure ≥ 130/85mmHg will receive either Losartan (50mg) or Valsartan (80mg) 1.2. Visit 1 at 1 month: In addition to Losartan (50mg) or Valsartan (80mg), patients with blood pressure ≥ 130/85mmHg will receive either Hydrochlorothiazide (12.5-25mg) or Amlodipine (5mg) 1.3. Visit 2 at 3 months: Patients with blood pressure ≥ 130/85mmHg will receive an increased dose of either Losartan (100mg) or Valsartan (160mg) and either Hydrochlorothiazide (12.5-25mg) or Amlodipine (5mg) 1.4. Visit 3 at 6 months: Patients with blood pressure ≥ 130/85mmHg will receive either Losartan (100mg) or Valsartan (160mg) and both Hydrochlorothiazide (12.5-25mg) and Amlodipine (5mg) 1.5. Visit 4 at 9 months: Patients with blood pressure ≥ 130/85mmHg will receive either Losartan (100mg) or Valsartan (160mg), Hydrochlorothiazide (12.5-25mg) and an increased dose of Amlodipine (10mg) 2. Angiotensin-Converting Enzyme (ACE) Inhibitor 2.1. Baseline visit: Patients with blood pressure ≥ 130/85mmHg will receive either Ramipril (5mg) or Perindopril (4mg) 2.2. Visit 1 at 1 month: In addition to Ramipril (5mg) or Perindopril (4mg), patients with blood pressure ≥ 130/85mmHg will receive either Hydrochlorothiazide (5-25mg) or Amlodipine (5mg) 2.3. Visit 2 at 3 months: Patients with blood pressure ≥ 130/85mmHg will receive an increased dose of either Ramipril (10mg) or Perindopril (8mg) and either Hydrochlorothiazide (12.5-25mg) or Amlodipine (5mg) 2.4. Visit 3 at 6 months: Patients with blood pressure ≥ 130/85mmHg will receive either Ramipril (10mg) or Perindopril (8mg) and both Hydrochlorothiazide (12.5-25mg) and Amlodipine (5mg) 2.5. Visit 4 at 9 months: Patients with blood pressure ≥ 130/85mmHg will receive either Ramipril (10mg) or Perindopril (8mg), Hydrochlorothiazide (12.5-25mg) and an increased dose of Amlodipine (10mg) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Losartan, valsartan, ramipril, perindopril, amlodipine, hydrochlorothiazide |
| Primary outcome measure | 1. Waist measurement, measured at baseline, 6 and 12 months 2. Blood samples for metabolic syndrome, DM and renal functions assessment, measured at baseline, 6 and 12 months 2.1. glycine 2.2. cholesterol measured additionally at 3 months and electively at 9 months 2.2.1. High Density Lipoprotein (HDL) 2.2.2. Low density Lipoprotein (LDL) 2.2.3. total cholesterol 2.3. triglycerides (TG) 2.4. uric acid 2.5. urea 2.6. creatinine 2.7. glycated haemoglobin 2.8. complete blood count 3. Blood pressure measurement at baseline. 6, 12 and 18 months 4. Microalbuminuria, paper measurement at baseline, 6 and 12 months Primary objective is to lower the absolute risk evaluated by Symptoms, Causes, Outcomes, Resources and Effects (SCORE) as well as to increase the number of patients with SCORE level below 5%. SCORE is an estimation of cardiovascular accident risk in next 10 years, calculated from data as: age, sex, systolic blood pressure, cholesterol level, history of smoking and diabetes mellitus. |
| Secondary outcome measures | 1. Percentage of patients with blood pressure < 140/90 mmHg 2. Percentage of patients with cholesterol < 5,0 mmol/l 3. Percentage of patients not complying with the criteria for metabolic syndrome 4. Renal function evaluated as glomerular filtration and microalbuminuria 5. Variation in glycated hemoglobin |
| Overall study start date | 20/11/2008 |
| Completion date | 30/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2000 |
| Key inclusion criteria | 1. Diabetes mellitus type II with primary hypertension (systolic pressure > 130 mmHg or diastolic pressure > 85 mmHg) 2. Two criteria of metabolic syndrome 3. Age > 40 4. Informed consent |
| Key exclusion criteria | 1. Myocardial infarction, stroke, Percutaneous Transluminal Coronary Angioplasty (PTCA), Coronary Artery Bypass Graft (CABG) in the last 3 months 2. Secondary hypertension 3. Clinically apparent heart failure 4. Diabetes mellitus type I 5. Comorbidity with bad prognosis (death expectation > 30%) 6. Gravidity and fertile women without sufficient contraception |
| Date of first enrolment | 20/11/2008 |
| Date of final enrolment | 30/05/2011 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Interní kardiologická klinika
Brno
62500
Czech Republic
62500
Czech Republic
Sponsor information
DSC Services, s.r.o. (Czech Republic)
Industry
Industry
Brnìnská 800
Tinov
666 03
Czech Republic
| Phone | +42 (0)77 7826208 |
|---|---|
| chroust@dscservices.cz | |
| Website | http://www.dscservices.cz/index-en.php |
"ROR" |
https://ror.org/04sw4ge25 |
Funders
Funder type
Industry
DSC Services, s.r.o. (Czech Republic)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
