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 |
| Protocol serial number | N/A |
| Sponsor | Heraklion University Hospital (Greece) |
| Funder | University of Crete School of Medicine (Greece) |
- 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
Scientific
Heraklion University Hospital
Stavrakia & Voutes
Heraklion
71409
Greece
| Phone | +30 2810 375 026 |
|---|---|
| cardio@med.uoc.gr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | The patients were randomised to 4 mg perindopril or placebo in an open-label, parallel-group, randomised design. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of angiotensin-converting enzyme inhibitors on systemic inflammation and myocardial sympathetic innervation in normotensive patients with type two diabetes mellitus |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Angiotensin-converting enzyme inhibitor (perindopril) |
| Primary outcome measure(s) |
Evaluation of total peroxides, interleukin-6 and a tumour necrosis factor-alpha were performed before and six months after the initiation of treatment. |
| Key secondary outcome measure(s) |
Assessment of cardiac adrenergic innervation before and after perindopril treatment. |
| Completion date | 25/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 65 |
| Total final enrolment | 62 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/12/2005 |
| Date of final enrolment | 25/06/2008 |
Locations
Countries of recruitment
- Greece
Study participating centre
Heraklion University Hospital
Heraklion
71409
Greece
71409
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not 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.
