TerminatedEarly Phase 1

Targeting ER Stress in Vascular Dysfunction

Stopped: IRB approval has been withdrawn

United States17 participantsStarted 2019-06-01

Plain-language summary

Aging and obesity are both risk factors for cardiovascular disease (CVD). One process that links both of these conditions to CVD is vascular dysfunction. Data from animal studies indicate that endoplasmic reticulum (ER) stress may play an important role in the development of endothelial dysfunction in aging and obesity. Therefore, the goal of this study is to investigate the relative contributions of aging and obesity on vascular dysfunction and ER stress. Additionally, this study will determine if taking an oral supplement for 8 weeks will improve vascular dysfunction and ER stress. Results from this study have the potential to identify a safe treatment option for improving vascular function in aging and obese populations.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Young, healthy weight adults (age: 18-35; BMI 18.5-24.9 kg/m2) * Young, obese adults (age: 18-35; BMI 30- 39.9 kg/m2) * Older, healthy weight adults (age: 60-80; 18.5-24.9 kg/m2) * Older, obese adults (age: 60-80; 30-39.9 kg/m2) Exclusion Criteria: * blood pressure \>140/90 mmHg * triglycerides \>500 mg/dL or LDL cholesterol \>190 mg/dL * current smoking or history of smoking in the last 12 months * diagnosed chronic disease including cancer, cardiovascular, diabetes, kidney, liver, and pancreatic disease * weight change \>3 kg in the past 3 months or actively trying to lose weight * \>12 alcoholic drinks/week * hormone replacement therapy

What they're measuring

Endothelium-dependent vasodilation

Timeframe: Change in baseline vasodilation at 8 weeks

Endothelium-independent vasodilation

Timeframe: Change in baseline vasodilation at 8 weeks

Aortic stiffness

Timeframe: Change in baseline pulse-wave velocity at 8 weeks

Endothelial cell ER stress marker ATF6

Timeframe: Change in baseline endothelial ATF6 at 8 weeks

Endothelial cell ER stress marker PERK

Timeframe: Change in baseline endothelial PERK at 8 weeks

Endothelial cell ER stress marker IRE1α

Timeframe: Change in baseline endothelial IRE1α at 8 weeks

Endothelial cell ER stress marker CHOP

Timeframe: Change in baseline endothelial CHOP at 8 weeks

Endothelial cell ER stress marker GRP78

Timeframe: Change in baseline endothelial GRP78 at 8 weeks

Trial details

NCT IDNCT04001647

SponsorColorado State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-16

View on ClinicalTrials.gov More Vasodilation trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Endothelium-dependent vasodilation

Timeframe: Change in baseline vasodilation at 8 weeks

Endothelium-independent vasodilation

Timeframe: Change in baseline vasodilation at 8 weeks

Aortic stiffness

Timeframe: Change in baseline pulse-wave velocity at 8 weeks

Endothelial cell ER stress marker ATF6

Timeframe: Change in baseline endothelial ATF6 at 8 weeks

Endothelial cell ER stress marker PERK

Timeframe: Change in baseline endothelial PERK at 8 weeks

Endothelial cell ER stress marker IRE1α

Timeframe: Change in baseline endothelial IRE1α at 8 weeks

Endothelial cell ER stress marker CHOP

Timeframe: Change in baseline endothelial CHOP at 8 weeks

Endothelial cell ER stress marker GRP78

Timeframe: Change in baseline endothelial GRP78 at 8 weeks