Cardiovascular Function Clinical Trial
Official title:
Investigation of the Influence of Gender on Cardiovascular Function and Inflammation
Verified date | June 2017 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Inflammation is a key initiating and damaging factor in many illnesses including infection, arthritis and cancer but also of particular relevance to this study in diseases of the heart and blood vessels (i.e. cardiovascular disease). Much evidence now exists demonstrating that male sex increases ones risk of cardiovascular disease. More recent evidence demonstrates that inflammatory responses in females appear to dampened in comparison to age matched males. Since inflammation is thought to be a key initiating phenomenon in many cardiovascular disease states the investigators will examine the differences in acute inflammatory responses between the sexes in healthy volunteers and the impact this has on the function of blood vessels.
Status | Completed |
Enrollment | 56 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: Healthy subjects aged 18-45 who have volunteered themselves and are willing to sign the consent form. Exclusion Criteria: 1. Healthy subjects unwilling to consent 2. History of hypertension, diabetes or hypertensive on BP measurement 3. Pregnant, or any possibility that a subject may be pregnant unless in the latter case a pregnancy test is performed with a negative result 4. History of any serious illnesses, including recent infections or trauma 5. Subjects taking systemic medication (other than the oral contraceptive pill) 6. Subjects with self-reported use of mouthwash or tongue scrapes 7. Subjects with recent or current antibiotic use 8. Subjects with a history, or recent treatment of (within last 3 months) of any oral condition (excluding caries), including gingivitis, periodontitis and halitosis. 9. Subjects that have recently participated (preceding 3 months) in any clinical studies involving administration of an inflammogen. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | William Harvey Heart Centre, Barts & The London Medical School | London |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London |
United Kingdom,
Hingorani AD, Cross J, Kharbanda RK, Mullen MJ, Bhagat K, Taylor M, Donald AE, Palacios M, Griffin GE, Deanfield JE, MacAllister RJ, Vallance P. Acute systemic inflammation impairs endothelium-dependent dilatation in humans. Circulation. 2000 Aug 29;102(9):994-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison change in blister fluid total and differential leukocyte numbers (Part 1) | plasma and fluid collected from the blisters at 24 hours (acute phase) and 72 hours (resolution phase) after the cantharidin application will be analysed using standard laboratory techniques including flow cytometry | 24, 72 h | |
Primary | Flow-mediated dilatation (Part 2) | Flow mediated dilatation of the brachial artery will be assessed using ultrasound will be measured at time 0, 24 and 48h. At the 16h timepoint a single typhoid vaccination will be administered in the arm or buttock. | 0, 24, 48 h | |
Secondary | Blood pressure (Part 1) | Blood pressure will be measured every 15 minutes for 1 hour | 0, 48, 72 h | |
Secondary | Platelet reactivity (Part 2) | Blood will be collected and platelet reactivity assessed using impedance aggreometry | 0, 24 and 48h | |
Secondary | Platelet activation (Part 2) | Blood will be collected and platelet p-selectin and platelet-monocyte expression determined using flow cytometry | 0,24 and 48h | |
Secondary | Arterial stiffness (Part 2) | The speed of blood pressure waves will be measured to give a pulse wave velocity measure for the aorta. | 0, 24 and 48h | |
Secondary | Inflammatory cell expression (Part 1 and 2) | Blood will be collected and inflammatory cell populations determined using flow cytometry | 0, 48, 72h part 1, 0, 24 and 48h part 2 | |
Secondary | Blood inflammatory molecule expression (Part 1 and 2) | Plasma will be collected for assessment of inflammatory markers | 0, 48, 72 h part 1, 0, 24 and 48h part 2, |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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