CompletedNot Applicable

Hyperglycemia and Mitochondrial Function in The Endothelium of Humans

United States35 participantsStarted 2016-03-09

Plain-language summary

In this study, the investigators will test the hypothesis that acute in vivo exposure to hyperglycemia increases mitochondrial network fragmentation and mitochondrial reactive oxygen species production (ROS) production in human arterial endothelial cells.

Who can participate

Age range

21 Years – 70 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

. Adult age 21 to 70
. No evidence of metabolic syndrome or diabetes, hypertension (BP≥140/90), or high cholesterol (LDL≥160) at the time of screening.

Exclusion criteria

. History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 40% on angiography or by confirmed history of myocardial infarction by standard criteria).
. History of bleeding disorders.
. Evidence of other evident major illness including chronic renal insufficiency (plasma creatinine \> 1.4 for women or 1.5 for men), liver disease (liver enzymes greater than 2.5 x normal), and cancer
. currently undergoing therapy or had therapy for cancer within 1 year of enrollment.
. Pregnancy as determined by urinary human chorionic gonadotropin beta test
. Thienopyridine, anti-thrombin/Xa, or warfarin therapy at time of screening
. On medication for cholesterol or blood pressure

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

Change in Mitochondrial Network Complexity of Endothelial Cells as Measured by Mitochondrial Network Fragment Ratio

Timeframe: Measured at 0,1, and 2 hours after administration

Trial details

NCT IDNCT02682342

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-28

Results submitted2024-11-22

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