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NCT Number: NCT07228208

Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes

Exaggerated blood pressure responses to exercise in individuals with Type 2 Diabetes significantly increase the risk of heart attack, stroke, and cardiovascular death, while also limiting exercise capacity and therapeutic benefits of physical activity. This research will determine whether impaired blood vessel function and excessive cellular damage from oxygen-containing molecules cause these dangerous blood pressure responses during exercise. The findings will establish whether targeting cellular antioxidant systems represents a new therapeutic approach to improve exercise tolerance and reduce cardiovascular risk in t Americans living with diabetes.

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Key information

Conditions

Type 2 Diabetes (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Endothelial Dysfunction Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location contact

William E Hughes, Ph.D.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes: 18 - 80 years old, able to give informed consent, > 6 months post-diagnosis, > 6 months stable medications for management
  • Healthy controls: 18 - 80 years old, able to give informed consent

Exclusion criteria

  • Type 2 Diabetes: Type 1 diabetes, symptomatic coronary artery disease, cardiovascular event in last year (MI, stroke), uncontrolled or unmanaged hypertension (>160/90 mmHg), heart failure, renal impairments, current or recent (<6 months) tobacco use, hormone replacement therapy, documented neuromuscular disorders, pregnancy
  • Healthy Controls: Same as listed in Type 2 Diabetes with Type 2 Diabetes as an exclusion factor

Treatment and study plan

MitoQ (mitoquinol mesylate)

Dietary Supplement

During each testing session, the investigators will be measuring how one treatment of an over-the-counter antioxidant supplement affects blood flow and muscle function. One day participants will orally ingest an over-the-counter antioxidant supplement called MitoQ.

Placebo

Dietary Supplement

During each testing session, the investigators will be measuring how one treatment of an over-the-counter antioxidant supplement affects blood flow and muscle function. One day participants will orally ingest an over-the-counter antioxidant supplement called MitoQ, while the other they will ingest a placebo

Primary outcomes

  1. Mean Arterial Pressure

    Time frame: Prior to and 45 minutes following supplement

    Change in mean arterial pressure is measured in response to handgrip exercise and post-exercise circulatory occlusion

  2. Heart Rate

    Time frame: Prior to and 45 minutes following supplement

    Change in heart rate is measured in response to handgrip exercise and post-exercise circulatory occlusion

Secondary outcomes

  1. Brachial Artery FMD

    Time frame: Prior to and 45 minutes following supplementation

    Brachial artery FMD a measure of endothelial function will be measured on the non-dominant arm

  2. Plasma MitoQ Concentration

    Time frame: Prior to and 45 minutes following supplementation

    Circulating concentrations of MitoQ is assessed in blood via venipuncture

  3. Muscle Tissue Oxygenation

    Time frame: Prior to and 45 minutes following supplementation

    We will also place a near-infrared spectroscopy (NIRS) pad on the thenar eminence of the non-paretic hand to non-invasively measure tissue oxygenation via infrared light following the pneumatic forearm cuff inflation/deflation.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Nov 14, 2025
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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