Targeting Endoplasmic Reticulum Stress in Human Hypertension
ConditionHypertension
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of North Texas Health Science Center
About this trial
There is strong evidence suggesting that endoplasmic reticulum stress contributes to neurogenic and vascular hypertension in various animal models, however this has never been explored in humans. Therefore, this project will fill this gap by performing a single-blind, placebo-controlled trial in humans with hypertension.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 80 years of age
No tobacco/nicotine use within preceding 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
Systolic blood pressure <140 mmHg; diastolic blood pressure <90 mmHg (obtained at the Screening and Familiarization Visit)
Normal 12-lead ECG (obtained at the Screening and Familiarization Visit and reviewed by a board-certified physician)
Disqualifiers
Not meeting the defined age criteria
Body mass index (BMI) >35 unless athletic/muscular build; calculation = body weight (kg)/height (m2)
Any tobacco/nicotine use within the last 6 months (e.g., cigarettes, chewing tobacco, nicotine gum or patches)
Positive pregnancy test
Trial design
Design model
Parallel
Treatments tested in this trial
TUDCA
DrugEndoplasmic reticulum stress will be inhibited by chronic (8 weeks) oral ingestion of the dietary supplement tauroursodeoxycholic acid (TUDCA; 1,750 mg/day)
Placebo
DrugPlacebo pills containing microcrystalline cellulose will be ingested over the course of the 8 week intervention.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Endoplasmic Reticulum Stress InhibitionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
24 hour Blood Pressure
Systolic and diastolic blood pressure will be measured twice per hour during the day and once per hour at night using a portable cuff.
Time frame
Within 1-2 weeks before and after intervention or placeboSecondary outcomes
1
Neurovascular Function
The microdialysis technique will be used to examine neurovascular function. To do this, blood flow will be measured in response to the local infusion of pharmacological agents that alter blood flow.
Time frame
Within 1-2 weeks before and after intervention or placebo2
Cardiac output
The amount of blood pumped from the heart each minute (i.e., cardiac output) be measured via inert gas (nitrous oxide) rebreathing
Time frame
Within 1-2 weeks before and after intervention or placebo3
Arterial Pulse Wave Velocity
Resting arterial compliance/stiffness will be assessed by measuring Doppler derived pulse wave velocity.
Time frame
Within 1-2 weeks before and after intervention or placebo4
Endoplasmic Reticulum Stress
Endoplasmic reticulum stress will be quantified by measuring the mRNA expression of spliced X-box binding protein 1 in a cutaneous biopsy sample obtained before and after the intervention.
Time frame
Within 1-2 weeks before and after intervention or placeboSponsors and contacts
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Source ClinicalTrials.gov