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

NCT07228208 | Not Yet Recruiting

• 1 other identifier: PRO00053449
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes (T2DM); Endothelial Dysfunction

Outcome Measures

Primary Outcomes (2)

• Mean Arterial Pressure

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

  Prior to and 45 minutes following supplement

• Heart Rate

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

  Prior to and 45 minutes following supplement

Secondary Outcomes (3)

• Brachial Artery FMD

  Prior to and 45 minutes following supplementation

• Plasma MitoQ Concentration

  Prior to and 45 minutes following supplementation

• Muscle Tissue Oxygenation

  Prior to and 45 minutes following supplementation

Study Arms (2)

Antioxidant Supplementation

EXPERIMENTAL

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

Dietary Supplement: MitoQ (mitoquinol mesylate)

Placebo

PLACEBO COMPARATOR

A placebo similar visually will be used to compare to MitoQ

Dietary Supplement: Placebo

Interventions

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.

Antioxidant Supplementation

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• William E Hughes, Ph.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 14, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)