Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/01/2010
Date assigned
27/05/2010
Last edited
27/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jindøich Špinar

ORCID ID

Contact details

Interní kardiologická klinika
Fakultní nemocnice Brno
Jihlavská 20
Brno
62500
Czech Republic
+42 (0)53 2232601
jspinar@fnbrno.cz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LF2008/01, version 1.0, date: 22.06.2008

Study information

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)

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?

Ethics approval

Multicentric Ethics Committee, University Hospital Brno Bohunice approved.

Study design

Multicentre open label randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Losartan, valsartan, ramipril, perindopril, amlodipine, hydrochlorothiazide

Primary outcome measures

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 trial start date

20/11/2008

Overall trial end date

30/05/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant 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

Recruitment start date

20/11/2008

Recruitment end date

30/05/2011

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Interní kardiologická klinika
Brno
62500
Czech Republic

Sponsor information

Organisation

DSC Services, s.r.o. (Czech Republic)

Sponsor details

Brnìnská 800
Tišnov
666 03
Czech Republic
+42 (0)77 7826208
chroust@dscservices.cz

Sponsor type

Industry

Website

http://www.dscservices.cz/index-en.php

Funders

Funder type

Industry

Funder name

DSC Services, s.r.o. (Czech Republic)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes