Diabetes, Pre-hypertension, Hypertension
Conditions
Keywords
aliskiren, endothelial function, hypertension
Brief summary
The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.
Detailed description
Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.
Interventions
DRUGaliskiren 300 mg once daily
aliskiren 300 mg daily
Sugar pill/placebo
Sponsors
Novartis
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * prehypertension or Stage 1 hypertension
Exclusion criteria
* Type 1 diabetes * Stage 2 hypertension * CKD * recent MI, revascularization, CVA or TIA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Flow-mediated Dilation | Baseline to 3 months | Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Central Aortic Pressure at 3 Months | 3 months after start of study | Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren aliskiren 300 mg daily | 10 |
| Placebo Sugar pill/placebo | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Placebo | Aliskiren | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 63.4 years STANDARD_DEVIATION 8.3 | 57.3 years STANDARD_DEVIATION 11 | 60.7 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 11 participants | 10 participants | 21 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
Change in Flow-mediated Dilation
Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | Change in Flow-mediated Dilation | 7.9 percentage of flow-mediated dilation | Standard Deviation 2.5 |
| Placebo | Change in Flow-mediated Dilation | 4.1 percentage of flow-mediated dilation | Standard Deviation 1.3 |
Secondary
Mean Central Aortic Pressure at 3 Months
Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)
Time frame: 3 months after start of study
Population: Aortic pressure indicates the augmentation pressure (AP) in mmHg derived from the radial artery waveform.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | Mean Central Aortic Pressure at 3 Months | aortic systolic blood pressure | 113.4 mm Hg | Standard Deviation 12 |
| Aliskiren | Mean Central Aortic Pressure at 3 Months | aortic diastolic blood pressure | 78.9 mm Hg | Standard Deviation 8.9 |
| Aliskiren | Mean Central Aortic Pressure at 3 Months | aortic pressure | 7.1 mm Hg | Standard Deviation 7.2 |
| Placebo | Mean Central Aortic Pressure at 3 Months | aortic systolic blood pressure | 122.3 mm Hg | Standard Deviation 9.6 |
| Placebo | Mean Central Aortic Pressure at 3 Months | aortic diastolic blood pressure | 83.3 mm Hg | Standard Deviation 9.9 |
| Placebo | Mean Central Aortic Pressure at 3 Months | aortic pressure | 10.3 mm Hg | Standard Deviation 5.7 |