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

NCT ID: NCT07228208

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-09-01

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes (T2DM) Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Antioxidant Supplementation

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

Group Type EXPERIMENTAL

MitoQ (mitoquinol mesylate)

Intervention Type 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.

Placebo

A placebo similar visually will be used to compare to MitoQ

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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William Hughes

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William E Hughes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Facility Contacts

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William E Hughes, Ph.D.

Role: primary

Other Identifiers

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PRO00053449

Identifier Type: -

Identifier Source: org_study_id

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