This trial is active, not recruiting.

Conditions hypertension, insulin resistance, microcirculation
Treatments irbesartan, felodipine, placebo
Sponsor Maastricht University Medical Center
Start date March 2008
End date July 2009
Trial size 32 participants
Trial identifier NCT00742066, MEC 07-2-115


In this study we hypothesize that blocking the angiotensin II AT1-receptor improves the insulin-induced microvascular dilatation. Objectives: 1. Does blockade of the angiotensin II AT1-receptor improve the insulin-induced microvascular effects in hypertensive patients. 2. Does blockade of the angiotensin II AT1-receptor impair the insulin-induced microvascular effects in normotensive control subjects?

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose basic science
irbesartan Aprovel C09CA04
Single dose 600mg orally
(Active Comparator)
felodipine Plendil C08CA02
single dose 10mg Felodipine ER
(Placebo Comparator)
Single dose tablet orally

Primary Outcomes

functional recruitment of capillaries in the skin
time frame: July 2009

Secondary Outcomes

perfused capillary density in the nailfold
time frame: July 2009
Endothelium- (in)dependent vasodilatation of finger skin microcirculation
time frame: July 2009
Density of arterioles, capillaries and venules in the bulbar conjunctiva.
time frame: July 2009
Diameter of arterioles and venules in the bulbar conjunctiva
time frame: July 2009

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: hypertensive subjects: 1. 18-60 years 2. Caucasian 3. untreated hypertension >140/90mmHg. normotensive subjects: 1. 18-60 years 2. Caucasian 3. Blood pressure <140/90 mmHg. Exclusion Criteria: 1. Obesity (BMI>27kg/m2) 2. Cardiovascular disease (stroke, coronary artery disease, peripheral vascular disease, heart failure) 3. Impaired glucose tolerance or diabetes mellitus according to the criteria of the ADA 4. Smoking 5. Alcohol use >4U/day 6. Use of medication (antihypertensive drugs, lipid lowering drugs, corticosteroids, NNSAIDs) 7. Pregnancy 8. Wearing contact lenses

Additional Information

Official title Insulin-induced Microvascular Activity in Patients With Essential Hypertension: a Possible Role for Angiotensin II AT1-receptor Blockers.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Maastricht University Medical Center.