Doppler ultrasound investigation of microvasculature in health and disease

Phase 1

• Conditions: Diabetes mellitus Hypertension

• Registration Number: EUCTR2006-005406-32-GB
• Lead Sponsor: Belfast City Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-26
• Study Completion: 2009-12-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified