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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02653638
Other study ID # 2015-0331
Secondary ID CVR-AAA4385A1760
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 2016
Est. completion date April 2019

Study information

Verified date December 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cerebral vasodilator responses to CO2 will be measured in young healthy adults, healthy sedentary older adults, and healthy exercise trained older adults. This variable will be examined before and after administering the cyclooxygenase inhibitor indomethacin, which has been shown to blunt cerebral vasodilator responses. In addition, the investigators will examine these counter-regulatory hemodynamic mechanisms to hypoperfusion caused by indomethacin.


Description:

Normal aging reduces cerebral blood flow and cognitive function. Aging also appears to alter functional connectivity within the brain, which is associated with cognitive functioning. Observational studies suggest that regular physical activity is associated with higher cerebral blood flow and improved cognitive function. However, the mechanistic links among regular physical activity and cerebral blood flow with advancing age are unknown. In this context, it is unclear if aging or exercise training status alters the neurovascular coupling of blood flow in the brain. Thus, the overall goal of this study is to examine the age-related changes in cerebral vasodilatory capacity, an important homeostatic mechanism and marker for effective regulation of cerebral perfusion, in order to determine how it is mechanistically linked to cognition. Additionally, the investigators will explore the potential beneficial effect of physical activity on the relationships between cerebral vasodilation and cognition in humans.

The research aims are:

1. To determine if cerebral vasodilator responses are affected by age and exercise training status in healthy adults.

2. To compare the effect of cyclooxygenase inhibition on cerebral vasodilator responses in healthy adults.

3. To determine the neurovascular counter-regulatory response to cyclooxygenase inhibition in healthy adults.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Young subjects between 18-35 years old

- Older subjects between 55-75 years old

- Nonsmokers

- Physically active (exercise more than 3 times per week for at least 30 minutes)

- Sedentary (no formal exercise over 1 hour per week).

Exclusion Criteria:

- Outside of the specified age range

- Present with history or evidence of hepatic, renal, or hematological disease; peripheral vascular disease; stroke/neurovascular disease; diabetes; hypertension

- Take medications that indicate hepatic, renal, hematological disease; cardiovascular disease, including hypertension; stroke/neurovascular disease; and diabetes

- Body mass index >34 kg/m2

- Take physician-prescribed medications that may interact with indomethacin: 1) cardiovascular drugs (e.g. angiotensin-converting-enzyme inhibitor (ACE inhibitors), angiotensin II receptor blockers (ARB's), Diuretics); 2) drugs that would increase bleeding risk (e.g. warfarin, heparin, clopidogrel, rivaroxaban, other NSAIDs); or 3) drugs associated with increased renal toxicity (e.g. cyclosporin, tacrolimus)

- Vulnerable populations (i.e. pregnant women, prisoners, individuals lacking capacity to consent, etc.)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Control
Transcranial Doppler Blood Pressure Heart Rate Oxygen Saturation
Drug:
Indomethacin
Transcranial Doppler Blood Pressure Heart Rate Oxygen Saturation

Locations

Country Name City State
United States Gymnasium-Natatorium Madison Wisconsin

Sponsors (3)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (41)

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* Note: There are 41 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Cerebral Vasodilator Responses Utilize a Transcranial Doppler to measure blood flow velocity in response to inhaled carbon dioxide. Measurement at baseline
Secondary Cerebral Vasodilator Responses Utilize a Transcranial Doppler to measure blood flow velocity in response to inhaled carbon dioxide. Measurement beginning 60 minutes post drug and measured through 180 minutes
Secondary Blood Pressure Measurement at baseline and beginning 60 minutes post drug and measured through 180 minutes
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