Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedical College of Wisconsin
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
MitoQ (mitoquinol mesylate)
Dietary supplementDuring 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 supplementDuring 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
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Antioxidant SupplementationExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean Arterial Pressure
Change in mean arterial pressure is measured in response to handgrip exercise and post-exercise circulatory occlusion
Time frame
Prior to and 45 minutes following supplement2
Heart Rate
Change in heart rate is measured in response to handgrip exercise and post-exercise circulatory occlusion
Time frame
Prior to and 45 minutes following supplementSecondary outcomes
1
Brachial Artery FMD
Brachial artery FMD a measure of endothelial function will be measured on the non-dominant arm
Time frame
Prior to and 45 minutes following supplementation2
Plasma MitoQ Concentration
Circulating concentrations of MitoQ is assessed in blood via venipuncture
Time frame
Prior to and 45 minutes following supplementation3
Muscle Tissue Oxygenation
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.
Time frame
Prior to and 45 minutes following supplementationSponsors and contacts
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Source ClinicalTrials.gov
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