Contact information
Type
Scientific
Primary contact
Prof Panos Vardas
ORCID ID
Contact details
Heraklion University Hospital
Stavrakia & Voutes
Heraklion
71409
Greece
+30 2810 375 026
cardio@med.uoc.gr
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Diabetes Mellitus (DM) may cause an increase in the inflammatory status and oxidative stress as well as sympathetic nervous system overactivity, even in the absence of any other organic heart disease. We investigate the effect of perindopril, an Angiotensin-Converting Enzyme inhibitor (ACE-i), on indexes of systemic inflammation and oxidative stress in normotensive patients with type two DM. We also examine the effect of the drug on the disturbances of left ventricular myocardial adrenergic innervation that may be seen in these patients.
Ethics approval
The ethics committee of Heraklion University Hospital approved the study on the 23rd May 2004 (ref: 4048/20-4-04).
Study design
The patients were randomised to 4 mg perindopril or placebo in an open-label, parallel-group, randomised design.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Type two Diabetes Mellitus (DM)
Intervention
The patients were randomly allocated by a computer algorithm to one of two groups for treatment with 4 mg perindopril per os or placebo for six months, in an open-label, parallel-group, randomised design.
Patients were required to visit the outpatients clinic one month, three months and six months after the initiation of treatment.
Intervention type
Drug
Phase
Not Specified
Drug names
Angiotensin-converting enzyme inhibitor (perindopril)
Primary outcome measures
Evaluation of total peroxides, interleukin-6 and a tumour necrosis factor-alpha were performed before and six months after the initiation of treatment.
Secondary outcome measures
Assessment of cardiac adrenergic innervation before and after perindopril treatment.
Overall trial start date
12/12/2005
Overall trial end date
25/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
The study population was recruited from the Cardiology Outpatients Department. All participants:
1. Had type two DM (World Health Organisation criteria)
2. Were diagnosed at an age over 30 years
3. Had DM controlled by diet or blood glucose-lowering agents for at least six months
4. Were normotensive (Blood Pressure [BP] less than 130/85 mmHg)
5. Had no indications of other organic heart disease
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
65
Participant exclusion criteria
1. Heavy smokers
2. Pregnant or lactating women
3. Type one DM or secondary diabetes
4. Previous or ongoing treatment with ACE-i, angiotensin receptor blockers, antioxidant or immunosuppressive agents
5. Systolic BP less than 100 mmHg or diastolic BP less than 50 mmHg
6. Poor glycaemic control
7. Hyperuricaemia
8. Previous history or medication for hypertension, cerebrovascular, liver or renal disease
9. Serum potassium more than 5 mEq/L
10. Albumin excretion rate more than 200 μg/min
11. History of drug or alcohol abuse
12. Any chronic inflammatory or other infectious disease during the last six months
13. Uncontrolled hypothyroidism
Recruitment start date
12/12/2005
Recruitment end date
25/06/2008
Locations
Countries of recruitment
Greece
Trial participating centre
Heraklion University Hospital
Heraklion
71409
Greece
Sponsor information
Organisation
Heraklion University Hospital (Greece)
Sponsor details
Cardiology Department
Stavrakia & Voutes
Heraklion
71409
Greece
+30 2810 375 026
cardio@ymed.uoc.gr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University of Crete School of Medicine (Greece)
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