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Stopped: IRB approval has been withdrawn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 range

18 Years – 80 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 80 Years

Sex

ALL

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