Diabetes Mellitus
Conditions
Brief summary
Purpose: To investigate the effect of Quinapril (Q) or Losartan (L) or their combination on definite Diabetic Autonomic Neuropathy (DAN) and left ventricular systolic and diastolic function (LVF) over a period of 4 years. Patients-methods: Fifty-nine patients with definite DAN \[2 or more of the 4 Cardiovascular Reflex Tests (CRTs) were abnormal\] were studied for 4 years. Patients were randomly allocated in 3 groups receiving A, 20 mg Q, B, 100 mg L and C, 20 mg Q +100 mg L respectively. CRTs analyzed with Mean Circular Resultant (MCR), Valsalva index, 30:15 ratio and postural hypotension. LV function was investigated with radionuclide ventriculography (RNV) at rest. Ejection fraction was used to assess LV systolic function, while peak filling rate, first third filling fraction, and atrial contribution to ventricular filling were used to investigate LV diastolic function. CRTs and RNV were performed at baseline and after 4 years.
Interventions
Sponsors
AHEPA University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>18 years old 2. Diabetes mellitus 3. Diabetic autonomic neuropathy
Exclusion criteria
1. Coronary artery disease 2. Arterial hypertension 3. Heart failure with reduced ejection fraction LVEF\<40% 4. Any contraindication to undergo radionuclide ventriculography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MCR | 4 years | Mean Circular Resultant |
| AV | 4 years | Atrial contribution to ventricular filling |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valsalva Index | 4 years | Valsalva Maneuver |
| 30:15 Index | 4 years | Variation of R-R interval during postural change |
| Postural hypotension | 4 years | Variation of systolic blood pressure during postural change (standing) |
| EF | 4 years | Left ventricular ejection fraction |
| E/I Index | 4 years | Expiration/Inspiration Index |
| PFR | 4 years | Peak filling rate Peak filling rate |
| 1/3 FF | 4 years | Filling fraction during the first third of the diastole |
| TPF/FT | 4 years | Time to peak filling time/filling time |
| PER | 4 years | Peak emptying rate |
| SD | 4 years | Standard Deviation |
Countries
Greece
Outcome results
None listed