Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/05/2007
Date assigned
12/06/2007
Last edited
12/06/2007
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 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

Publication citations

Additional files

Editorial Notes