Acetylcholine for Vasodilation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorado State University, Fort Collins, CO
Vasodilation+1 More
Acetylcholine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a supplement may help improve vascular function in aging and obese populations.

See full description

Eligible Conditions

  • Vasodilation
  • Stiffness, Arterial

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Vasodilation

Study Objectives

This trial is evaluating whether Acetylcholine will improve 17 primary outcomes and 10 secondary outcomes in patients with Vasodilation. Measurement will happen over the course of Change in baseline endothelial MnSOD at 8 weeks.

Week 8
Circulating CRP
Week 8
Circulating IL-10
Week 8
Circulating IL-18
Week 8
Circulating IL-1β
Week 8
Circulating IL-6
Week 8
Circulating TNFα
Week 8
Circulating glucose
Week 8
Endothelial cell ER stress marker ATF6
Week 8
Endothelial cell ER stress marker CHOP
Week 8
Endothelial cell oxidative stress marker CuZnSOD
Week 8
Endothelial cell ER stress marker GADD34
Week 8
Endothelial cell ER stress marker GRP78
Week 8
Endothelial cell inflammatory marker IL-6
Week 8
Endothelial cell ER stress marker IRE1α
Week 8
Endothelial cell inflammatory marker IκBα
Week 8
Endothelial cell oxidative stress marker MnSOD
Week 8
Endothelial cell oxidative stress marker NT
Week 8
Endothelial cell ER stress marker PERK
Week 8
Endothelial cell inflammatory marker TNFα
Week 8
Endothelial cell oxidative stress marker p47phox
Week 8
Endothelial cell inflammatory marker p65
Week 8
Circulating insulin
Week 8
Aortic stiffness
Week 8
Circulating cholesterol
Week 8
Circulating triglycerides
Week 8
Endothelium-dependent vasodilation
Endothelium-independent vasodilation

Trial Safety

Safety Progress

1 of 3

Other trials for Vasodilation

Trial Design

2 Treatment Groups

TUDCA
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Acetylcholine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

TUDCAYoung and older healthy weight and obese participants will visit the lab for assessment of vascular function prior to the intervention. Aortic stiffness will be evaluated non-invasively using carotid-femoral pulse-wave velocity. A physician will place a catheter in the brachial artery for endothelial cell biopsies and local vasodilator infusions. A venous catheter will also be placed for the systemic ascorbic acid infusion. Aortic stiffness measures and vascular responses to vasodilator infusions will be performed before and after the ascorbic acid infusion. Following the completion of the vascular assessments, participants will receive 1750 mg/day of the dietary supplement tauroursodeoxycholic acid (TUDCA) for 8 weeks. Participants will return to the lab after the 8 week intervention and the vascular assessments described above will be repeated.
PlaceboOlder obese participants will visit the lab for assessment of vascular function prior to the intervention. Aortic stiffness will be evaluated non-invasively using carotid-femoral pulse-wave velocity. A physician will place a catheter in the brachial artery for endothelial cell biopsies and local vasodilator infusions. A venous catheter will also be placed for the systemic ascorbic acid infusion. Aortic stiffness measures and vascular responses to vasodilator infusions will be performed before and after the ascorbic acid infusion. Following the completion of the vascular assessments, participants will receive oral capsules containing a placebo treatment for 8 weeks. Participants will return to the lab after the 8 week intervention and the vascular assessments described above will be repeated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ascorbic acid
FDA approved
Acetylcholine
FDA approved
Nitroprusside
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in baseline insulin at 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change in baseline insulin at 8 weeks for reporting.

Who is running the study

Principal Investigator
F. D.
Prof. Frank Dinenno, Professor
Colorado State University

Closest Location

Colorado State University - Fort Collins, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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, obese adults (age: 60-80; 30-39.9 kg/m2)
Older, healthy weight adults (age: 60-80; 18.5-24.9 kg/m2)

Patient Q&A Section

Can vasodilation be cured?

"The treatment of pulmonary hypertension with NO and prostaglandins has had a large beneficial effect on patients, mainly due to improved arterial oxygenation. In patients with pulmonary hypertension, vasodilation of the pulmonary arteries with NO can be cure with low-dose vasodilators or by suppressing right-heart failure-related increase in aortic stiffness. Pulmonary hypertension, however, must be considered a lifelong necessity." - Anonymous Online Contributor

Unverified Answer

What is vasodilation?

"Vasodilation can cause increased blood flow in arteries and capillaries and it induces the release of arterial and capillary dilating hormones that activate various pathways that lead to the opening of potassium ion channels and the formation of a hyperpolarizing hyperpolarization potential and, at a more rapid rate, calcium-activated potassium channels.\n\n- Overview at kennej.com"" - Anonymous Online Contributor

Unverified Answer

What causes vasodilation?

"There is a close association between age, female sex and lower plasma angiotensin II. This might be because vasodilation is generally required to limit circulating blood pressure, and reduced angiotensin II levels could in consequence lead to higher blood pressure and, therefore, increased disease risk." - Anonymous Online Contributor

Unverified Answer

What are common treatments for vasodilation?

"The most common treatment for vasodilation is medications. This is a first step in the treatment for vasodilation. Although this treatment is not an absolute cures for vasodilation and patients may have to take a different type of medication over the course of time in order to achieve results. The number of people affected at one time might be quite small. All people should still keep a diary of signs and symptoms of vasodilation as well as records of what treatments have been taken. Any of the medications used to treat vasodilation could cause blood clotting to be activated. The activated clotting helps to prevent any blood clots because the clotting is not active until it feels that the blood needs to clot." - Anonymous Online Contributor

Unverified Answer

How many people get vasodilation a year in the United States?

"Most Americans have vasodilation using a mean of 1.5 sprays/day, although fewer than half of those people use vasodilators more than one sputum time a day." - Anonymous Online Contributor

Unverified Answer

What are the signs of vasodilation?

"The signs of vasodilation could be seen with the naked eye and include: pale, cool face, blue discoloration of the hands and feet, and red/yellow cheeks and nose. The signs of vasodilation can be seen with the naked eye as the redness and heat from the red skin can be seen by placing one's hand on an erythrocyte agglomeration. If one experiences symptoms such as dizziness, fainting, and weakness, one should immediately seek medical attention. The symptoms of vasodilation are not always present; therefore, there must be close and close observation. It is important to keep a history of symptoms and physical examination." - Anonymous Online Contributor

Unverified Answer

How does acetylcholine work?

"Acetylcholine is known to induce bronchoconstriction; but a new idea is that this action may serve to open pulmonary arteries and capillary blood vessels in lungs which might result in improved exchange of oxygen and carbon dioxide, thus increasing the elimination of carbon dioxide on the lung surface which ultimately results in improved gas exchange. This effect may explain why people with COPD often hyperventilate, and why their symptoms improve on using inhaling a mixture of nitric oxide and xenon (NO2X)." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating vasodilation?

"There has not been any new discoveries for treating vasodilation. The most important thing is to learn the mechanism of vasodilation, in order to find treatments for vasodilation, which is a common complaint of many patients." - Anonymous Online Contributor

Unverified Answer

Has acetylcholine proven to be more effective than a placebo?

"The ACh test can show improvement in the symptoms of patients with vasovagal syncope, a medical condition which can mimic panic attacks. The test does not show any improvement in the severity of vasovagal syncope and does not show any better results than a placebo would have shown." - Anonymous Online Contributor

Unverified Answer

Does vasodilation run in families?

"While there is no evidence for a simple, heritable model to explain MHRV, a model that is more complex than familial susceptibility to cardiovascular disease is required." - Anonymous Online Contributor

Unverified Answer

Does acetylcholine improve quality of life for those with vasodilation?

"It has been shown that vasodilation with acetylcholine improves quality of life for people with severe peripheral arterial disease. With further research, this method could be a new and effective treatment for people with PAD." - Anonymous Online Contributor

Unverified Answer

Is acetylcholine safe for people?

"Results from a recent paper, a submaximal high dose of ACh resulted in a sustained peripheral vasoconstriction and mydriasis. No other major side-effects were observed. Further studies with larger numbers of patients are required to assess the possible clinical significance." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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