Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MitoQ (mitoquinol mesylate), Placebo.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes (T2DM), Endothelial Dysfunction. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement MitoQ (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 supplement Placebo
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 outcome measures
- Mean Arterial Pressure [Time frame: Prior to and 45 minutes following supplement]
- Heart Rate [Time frame: Prior to and 45 minutes following supplement]
Secondary outcome measures (3)
- Brachial Artery FMD [Time frame: Prior to and 45 minutes following supplementation]
- Plasma MitoQ Concentration [Time frame: Prior to and 45 minutes following supplementation]
- Muscle Tissue Oxygenation [Time frame: Prior to and 45 minutes following supplementation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07228208 · PRO00053449