MEDINA: Metabolic syndrome, diabetes mellitus and renal protection

MEDINA: Metabolic syndrome, diabetes mellitus and renal protection: an open label, randomised, controlled, parallel group trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN61411165

Enrollment

2000

Registered

2010-05-27

Start date

2008-11-20

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Czech Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026