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

Medical College of Wisconsin

Status: Begins enrollment in 6 months

Conditions: Type 2 Diabetes (T2DM); Endothelial Dysfunction

Treatments: Dietary Supplement: MitoQ (mitoquinol mesylate); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07228208

PRO00053449

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Antioxidant Supplementation

Experimental group

Description:

MitoQ, a mitochondrial target antioxidant, given once at a dose of 160 mg

Treatment:

Dietary Supplement: MitoQ (mitoquinol mesylate)

Placebo

Placebo Comparator group

Description:

A placebo similar visually will be used to compare to MitoQ

Treatment:

Dietary Supplement: Placebo