Effect of angiotensin-converting enzyme inhibitors on systemic inflammation and myocardial sympathetic innervation in normotensive patients with type two diabetes mellitus

ISRCTN ISRCTN76608550
DOI https://doi.org/10.1186/ISRCTN76608550
Secondary identifying numbers N/A
Submission date
21/05/2007
Registration date
12/06/2007
Last edited
25/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Panos Vardas
Scientific

Heraklion University Hospital
Stavrakia & Voutes
Heraklion
71409
Greece

Phone +30 2810 375 026
Email cardio@med.uoc.gr

Study information

Study designThe patients were randomised to 4 mg perindopril or placebo in an open-label, parallel-group, randomised design.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffect of angiotensin-converting enzyme inhibitors on systemic inflammation and myocardial sympathetic innervation in normotensive patients with type two diabetes mellitus
Study objectivesDiabetes 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(s)The ethics committee of Heraklion University Hospital approved the study on the 23rd May 2004 (ref: 4048/20-4-04).
Health condition(s) or problem(s) studiedType two Diabetes Mellitus (DM)
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Angiotensin-converting enzyme inhibitor (perindopril)
Primary outcome measureEvaluation of total peroxides, interleukin-6 and a tumour necrosis factor-alpha were performed before and six months after the initiation of treatment.
Secondary outcome measuresAssessment of cardiac adrenergic innervation before and after perindopril treatment.
Overall study start date12/12/2005
Completion date25/06/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants65
Total final enrolment62
Key inclusion criteriaThe 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
Key exclusion criteria1. 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
Date of first enrolment12/12/2005
Date of final enrolment25/06/2008

Locations

Countries of recruitment

  • Greece

Study participating centre

Heraklion University Hospital
Heraklion
71409
Greece

Sponsor information

Heraklion University Hospital (Greece)
Hospital/treatment centre

Cardiology Department
Stavrakia & Voutes
Heraklion
71409
Greece

Phone +30 2810 375 026
Email cardio@ymed.uoc.gr
ROR logo "ROR" https://ror.org/0312m2266

Funders

Funder type

University/education

University of Crete School of Medicine (Greece)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 29/11/2007 25/10/2021 Yes No

Editorial Notes

25/10/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.