|
Welcome
|
|
10 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| MEDINA: Metabolic syndrome, diabetes mellitus and renal protection |
| ISRCTN | ISRCTN61411165 |
| ClinicalTrials.gov identifier | |
| Public title | MEDINA: Metabolic syndrome, diabetes mellitus and renal protection |
| Scientific title | MEDINA: Metabolic syndrome, diabetes mellitus and renal protection: an open label, randomised, controlled, parallel group trial |
| Acronym | MEDINA (metabolický syndrom, diabetes mellitus a nefroprotektivita) |
| Serial number at source | LF2008/01, version 1.0, date: 22.06.2008 |
| Study hypothesis |
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? |
| Lay summary | |
| Ethics approval |
Multicentric Ethics Committee, University Hospital Brno Bohunice approved.
|
| Study design | Multicentre open label randomised active controlled parallel group trial |
| Countries of recruitment | Czech Republic |
| Disease/condition/study domain | Metabolic syndrome; diabetes mellitus; hypertension |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 20/11/2008 |
| Anticipated end date | 30/05/2011 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 2000 |
| Interventions |
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) |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | DSC Services, s.r.o. (Czech Republic) |
| Trial website | |
| Publications | |
| Contact name | Prof Jindøich Špinar |
| Address |
Interní kardiologická klinika
Fakultní nemocnice Brno Jihlavská 20 |
| City/town | Brno |
| Zip/Postcode | 62500 |
| Country | Czech Republic |
| Tel | +42 (0)53 2232601 |
| Fax | +42 (0)53 2232611 |
| jspinar@fnbrno.cz | |
| Sponsor | DSC Services, s.r.o. (Czech Republic) |
| Address | Brnìnská 800 |
| City/town | Tišnov |
| Zip/Postcode | 666 03 |
| Country | Czech Republic |
| Tel | +42 (0)77 7826208 |
| Fax | +42 (0)54 9497764 |
| chroust@dscservices.cz | |
| Sponsor website: | http://www.dscservices.cz/index-en.php |
| Date applied | 13/01/2010 |
| Last edited | 27/05/2010 |
| Date ISRCTN assigned | 27/05/2010 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|