Type 2 Diabetes (T2DM)NCT07228208
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
A study testing MitoQ (mitoquinol mesylate) in people with Type 2 Diabetes (T2DM) and Endothelial Dysfunction, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes (T2DM), Endothelial Dysfunction
- What is being tested?
- MitoQ (mitoquinol mesylate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
William E Hughes, Ph.D., whughes@mcw.edu
About this study
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
- Being tested
- MitoQ (mitoquinol mesylate), Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant Supplementation | Experimental | MitoQ, a mitochondrial target antioxidant, given once at a dose of 160 mg Receives: Dietary Supplement: MitoQ (mitoquinol mesylate) |
| Placebo | Placebo comparator | A placebo similar visually will be used to compare to MitoQ Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure
Change in mean arterial pressure is measured in response to handgrip exercise and post-exercise circulatory occlusion
Measured: 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
Measured: Prior to and 45 minutes following supplement
Secondary outcomes (3)
Brachial Artery FMD
Brachial artery FMD a measure of endothelial function will be measured on the non-dominant arm
Measured: Prior to and 45 minutes following supplementation
Plasma MitoQ Concentration
Circulating concentrations of MitoQ is assessed in blood via venipuncture
Measured: Prior to and 45 minutes following supplementation
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.
Measured: Prior to and 45 minutes following supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to either active or placebo supplement, acting as their own control
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Hughes, Medical College of Wisconsin
- Investigators
- William E Hughes, Ph.D., Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228208
- Sponsor's protocol ID
- PRO00053449
- Status last verified
- Sep 2025
- First submitted
- 5 Nov 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07228208
- Acronym / sponsor ID
- PRO00053449
- Conditions
- Type 2 Diabetes (T2DM), Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either active or placebo supplement, acting as their own control
| Arm | Type | Receives |
|---|---|---|
| Antioxidant Supplementation | Experimental | Dietary Supplement: MitoQ (mitoquinol mesylate)MitoQ, a mitochondrial target antioxidant, given once at a dose of 160 mg |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA placebo similar visually will be used to compare to MitoQ |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Antioxidant Supplementation |
| PlaceboDuring 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 | Dietary supplement | Placebo |
Primary outcome
Mean Arterial Pressure
Time frame: Prior to and 45 minutes following supplement
Change in mean arterial pressure is measured in response to handgrip exercise and post-exercise circulatory occlusion
Heart Rate
Time frame: Prior to and 45 minutes following supplement
Change in heart rate is measured in response to handgrip exercise and post-exercise circulatory occlusion
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William E Hughes, Ph.D. principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MitoQ (mitoquinol mesylate) in people with Type 2 Diabetes (T2DM) and Endothelial Dysfunction, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (time frame: Prior to and 45 minutes following supplement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.