Clinical trial NCT04956861: HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
Official title: HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1
Keywords: Sleep
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and tissue-type plasminogen activator release in anti-retroviral (ART)-treated HIV-1-seropositive adults. Furthermore, the investigators hypothesize that the postulated diminishment in endothelial vasodilator and fibrinolytic function with insufficient sleep will be due, at least in part, to increased oxidative stress. Moreover, increasing sleep duration and improving sleep quality will increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in ART-treated HIV-1-seropositive adults. Increases in endothelial vasodilator and fibrinolytic function will be due, at least in part, to reduced oxidative stress.


Eligibility criteria: Inclusion Criteria:

* Subjects will be men and women of all races and ethnic backgrounds aged 40-75 years with documented HIV-1 infection.
* Subjects will be HIV-1-seropositive individuals on a stable DHHS approved ART regimen for at least 6 months, with documented virologic suppression (\<50 copies HIV-1 RNA/mL) for at least 3 months.
* All subjects must have CD4+ T cell counts \>200 cells/mm3 at the time of study entry.
* Subjects will be free of overt CVD as assessed by: a) medical history; b) physical examination; c) electrocardiogram and BP at rest and maximal exercise; d) complete blood chemistries, lipid and lipoprotein, glucose, insulin and hematological evaluation.
* All candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (\<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.

Exclusion Criteria:

* Receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
* Pre- or peri-menopausal women

Primary outcomes:
measure: Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh)
timeFrame: FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
measure: Phase 2: FBF Response to Acetylcholine (ACh)
timeFrame: FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
measure: Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)
timeFrame: FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
measure: Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP)
timeFrame: FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
measure: Phase 1: Endothelial Tissue Type Plasminogen Activator (t-PA) Release in Response to Bradykinin (BDK)
timeFrame: t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
measure: Phase 2: Endothelial t-PA Release in Response to Bradykinin (BDK)
timeFrame: t-PA release will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
measure: Phase 1: FBF Response to ACh+Ng-monomethyl-L-arginine (L-NMMA)
timeFrame: FBF response to ACh+L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
measure: Phase 1: FBF Response to ACh+Vitamin C
timeFrame: FBF response to ACh+Vitamin C will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
measure: Phase 2: FBF Response to ACh+L-NMMA
timeFrame: FBF response to ACh+L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
measure: Phase 2: FBF Response to ACh+Vitamin C
timeFrame: FBF response to ACh+Vitamin C will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Secondary outcomes:
measure: Nightly Sleep Duration
timeFrame: Baseline
Other outcomes:
Locations:
city: Boulder
country: United States
facility: UC-Boulder Clinical and Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Christopher DeSouza, PhD
role: PRINCIPAL_INVESTIGATOR
References: