Diabetes mellitus Hypertension
Conditions
Interventions
Trade Name: Ramipril
Pharmaceutical Form: Capsule*
INN or Proposed INN: RAMIPRIL
CAS Number: 87333195
Concentration unit: mg milligram(s
Sponsors
Belfast City Hospital Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants with diabetes - Type 1 diabetes - Age between 18 and 55 years Participants with hypertension - Systolic blood pressure greater than or equal to 140 mmHg, and/or diastolic blood pressure greater than or equal to 90 mmHg - Age between 18 and 55 years Control subjects - Age and sex matched controls to the above participants Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants with diabetes - Known coronary, cerebrovasular, peripheral vascular or reno-vascular disease - HbA1C greater than or equal to 10% (a blood test indicating degree of control of diabetes) - On 2 or more medications for hypertension or diabetic renal disease - Proliferative retinopathy - Past or present retinal laser treatment - Systolic blood pressure greater than 140 or less than 110 mmHg - Diastolic blood pressure greater than 90 or less than 60 mmHg - Total cholesterol greater than 6.0 mmol/l - LDL cholesterol greater than 3.0 mmol/l - Estimated glomerular filtration rate less than 60 ml/min/1.73m2 - Pregnancy or breast feeding - Electrolyte or significant liver function abnormalities - Known hypersensitivity to ACE inhibitors - Any significant other medical illness Hypertension - Known coronary, cerebrovasular, peripheral vascular or reno-vascular disease - Random venous glucose greater than 6.1 mmol/l - Diabetes mellitus - On 2 or more medications for hypertension - Systolic blood pressure greater than or equal to 160 mmHg or Diastolic blood pressure greater than or equal to 100 mmHg if on no anti-hypertensive therapy - Systolic blood pressure greater than or equal to 150 mmHg or Diastolic blood pressure greater than or equal to 90 mmHg if on anti-hypertensive therapy - Total cholesterol greater than 6.0 mmol/l - LDL cholesterol greater than 3.0 mmol/l - Estimated glomerular filtration rate less than 60 ml/min/1.73m2 - Pregnancy or breast feeding - Electrolyte or significant liver function abnormalities - Known hypersensitivity to ACE inhibitors - Any significant other medical illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Analysis of the shape of pressure waves in arteries permits the detection of abnormalities in the circulation. Such changes have been shown to predict future complications in patients with diabetes mellitus or high blood pressure (hypertension). We plan to study the shape of pressure waves in various arteries around the body using an ultrasound scanner. We will investigate whether abnormalities are generalisable, or whether they are confined to particular organ beds.; Secondary Objective: We also plan to investigate the effects of the drug ramipril on arterial waveshape. Comparison with the effects of another drug, bendroflumethiazide, will separate out blood-pressure lowering effects from other actions of the drug. We also aim to relate change in the ultrasound signal from the central retinal artery to changes in shape and size of the blood vessels at the back of the eye in response to inhaling oxygen and carbon dioxide. This can be done by taking photographs of the back of the eye. ; Primary end point(s): Waveform recordings taken from the brachial, ophthalmic, central retinal, carotid and renal arteries. | — |
Countries
United Kingdom
Outcome results
None listed