MEDINA: Metabolic syndrome, diabetes mellitus and renal protection

ISRCTN	ISRCTN61411165
DOI	https://doi.org/10.1186/ISRCTN61411165
Protocol serial number	LF2008/01, version 1.0, date: 22.06.2008
Sponsor	DSC Services, s.r.o. (Czech Republic)
Funder	DSC Services, s.r.o. (Czech Republic)

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

Interní kardiologická klinika
Fakultní nemocnice Brno
Jihlavská 20
Brno
62500
Czech Republic

Phone	+42 (0)53 2232601
Email	jspinar@fnbrno.cz

Study information

Primary study design	Interventional
Study design	Multicentre open label randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Losartan, valsartan, ramipril, perindopril, amlodipine, hydrochlorothiazide
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.
Key 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
Completion date	30/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan