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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07228208
Enrollment
40
Registered
2025-11-14
Start date
2026-09-01
Completion date
2031-12-31
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Type 2 Diabetes (T2DM)

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTMitoQ (mitoquinol mesylate)

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.

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Participants will be randomized to either active or placebo supplement, acting as their own control

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Arterial PressurePrior to and 45 minutes following supplementChange in mean arterial pressure is measured in response to handgrip exercise and post-exercise circulatory occlusion
Heart RatePrior to and 45 minutes following supplementChange in heart rate is measured in response to handgrip exercise and post-exercise circulatory occlusion

Secondary

MeasureTime frameDescription
Brachial Artery FMDPrior to and 45 minutes following supplementationBrachial artery FMD a measure of endothelial function will be measured on the non-dominant arm
Plasma MitoQ ConcentrationPrior to and 45 minutes following supplementationCirculating concentrations of MitoQ is assessed in blood via venipuncture
Muscle Tissue OxygenationPrior to and 45 minutes following supplementationWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026