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Type 2 DiabetesEarly Phase 1NCT05593549

Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction

A Early Phase 1 study testing Trehalose in people with Type 2 Diabetes and Healthy Aging, run by Medical College of Wisconsin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to examine the role of autophagy on microvascular function in adults with Type 2 Diabetes. The main question it aims to answer are: Does presence of Type 2 Diabetes reduce autophagy and impair microvascular function? Does exposure to high glucose impair autophagy and subsequently… 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, Healthy Aging
What is being tested?
Trehalose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Jan 2023to 31 Dec 2029
Phase
Early Phase 1
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

None listed.

Who cannot join

  • Uncontrolled hypertension
  • Current Tobacco use or within last 6 months
  • BMI > 35
  • Hyperlipidemia
  • Hypercholesterolemia
  • Type 1 Diabetes
Show all 21Show fewer
  • Use of anti-coagulant drugs, or anti-platelet drugs
  • Symptomatic coronary artery disease
  • Heart Failure
  • Renal Impairment
  • Hormone Replacement Therapy
  • History of Retinopathy
  • Documented Neuromuscular Disorders
  • Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity)
  • Pregnancy (Young Female subjects)
  • Allergies to Povidone Iodine
  • Use Erectile Dysfunction Medication in the past 6 months
  • Use of Topical/non-topical Steroids in last 6 months
  • Active Anti-Cancer Treatment or Treatment within last 12 months
  • Active COVID-19 or within the past 3 months
  • Gender Reassignment Therapy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

William Hughes, Ph.D. contact

414-955-7519

whughes@mcw.edu

United States1 site, 1 recruiting
  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    William Hughes, Ph.D., whughes@mcw.edu

    Recruiting

Other trials in United States

About this study

The goal of this clinical trial is to examine the role of autophagy on microvascular function in adults with Type 2 Diabetes. The main question it aims to answer are:

  • Does presence of Type 2 Diabetes reduce autophagy and impair microvascular function?
  • Does exposure to high glucose impair autophagy and subsequently microvascular function?

Participants will undergo 2 study days. The primary outcome will be in vivo microvascular function testing. Following the first study day participants will undergo either supplementation with trehalose, an autophagy activator, or placebo for 14 days. The second study day will test in vivo microvascular function.

Read the detailed description

It is generally accepted that endothelial dysfunction precedes overt cardiovascular disease and is a foundational event in development of atherosclerosis. Endothelial function is often assessed by flow-mediated dilation (FMD), a physiological response to shear stress along the endothelium that elicits vasodilation via release of nitric oxide (NO) in large and small blood vessels. In the presence of Coronary Artery Disease (CAD), NO production is reduced and FMD is diminished in conduit arteries. However, in the microcirculation, FMD is preserved but there is a compensatory shift from NO to hydrogen peroxide (H2O2) as the mediator of this dilation. The investigators lab has previously identified several signaling pathways, including autophagy, that are involved in regulating the switch in mechanism of dilation from NO to H2O2 utilizing ex vivo isolated arteriole preparations in CAD. In this trial, the investigators explore the possible role of autophagy as mechanism by which this switch occurs in a population at-risk for cardiovascular disease. Macroautophagy (referred to as autophagy here forward) is a scalable process designed to recycle damaged organelles via acidic hydrolases in lysosomes to maintain homeostasis. The rationale for examining a role for autophagy stems from data in cultured endothelial cells showing that autophagy can regulate NO bioavailability and reactive oxygen species (ROS) production. Inhibition of key autophagy proteins decreases NO production and increases ROS endothelial cells are exposed to shear stress, markers of autophagy increase, along with a rise in NO production. The investigators have recently demonstrated that autophagic flux is repressed in response to shear stress in arterioles from patients with CAD compared to healthy controls. This disease-associated reduction in autophagic flux increases release of H2O2 from the mitochondria in response to shear stress. Activation or repression of autophagy in CAD and healthy arterioles, respectively, switches the mechanism of dilation (activation in CAD switches to NO; repression in healthy controls switches to H2O2). Collectively, microvascular autophagic flux plays a key role integrating cellular signals within the endothelium to regulate microvascular health and function in response to shear stress in overt cardiovascular disease. The primary cellular mechanisms for this pathological switch in in vasodilator mechanism and its relevance in other at-risk populations (e.g., type 2 diabetes mellitus; T2DM) remains unclear.

Hyperglycemia, Type 2 Diabetes Mellitus and Microvascular Function T2DM, a chronic metabolic disease, is an independent risk factor for cardiovascular disease. Hyperglycemia is a hallmark of T2DM, and both T2DM and hyperglycemia are independently linked to endothelial dysfunction. While hyperglycemia in T2DM is often well-managed with medication, damaging microvascular consequences such as diabetic neuropathy and cardiomyopathy persist, and T2DM subjects demonstrate reduced microvascular endothelial-dependent dilation. While ex vivo interrogation of vasodilator mechanisms provides mechanistic insight into microvascular control, the lack of translation to in vivo models represents a large gap in knowledge. The investigators have devised a research strategy to directly study and fill this research gap, answering key questions regarding the change in endothelial mediators that occurs with cardiovascular disease in human tissue. T2DM and high glucose (HG) exposure are associated with reduced cutaneous microvascular endothelial function ex vivo and in vivo. However, the mechanism by which this reduction occurs is unclear. Furthermore, it is not known whether exposure to high glucose alone, or the presence of T2DM are associated with a switch in the mechanism of microvascular dilation to shear stress. Understanding and translating ex vivo findings to in vivo settings will provide insight into the disease pathology and novel approaches to ameliorate T2DM microvascular dysfunction.

Considering the important link between T2DM/HG-induced microvascular dysfunction and risk of future cardiovascular events, stimulation of autophagic flux may enhance or preserve available NO, exerting beneficial effects on microvascular function in patients with T2DM and in response to HG. The purpose of this proposal is to investigate the fundamental role of autophagy in contributing to T2DM microvascular dysfunction in a comprehensive manner. The results of this study may inform the mechanistic understanding of microvascular disease progression in T2DM.

Objective: Establish a mechanistic role for autophagic flux in contributing to T2DM-associated microvascular dysfunction in vivo utilizing the human cutaneous microcirculation as a novel translational model.

Hypothesis 1: Activation of autophagic flux with trehalose for 2 weeks in T2DM subjects enhances cutaneous dilation to endothelial-dependent pharmacological agonists (microdialysis) and local thermal hyperemia.

Hypothesis 2: Exposure to HG (oral glucose challenge) in healthy adults reduces cutaneous dilation to endothelial-dependent pharmacological agonists and local thermal hyperemia.

Being tested
Trehalose, Placebo
Keywords
autophagy, microvascular function, laser doppler microdialysis
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.

  • TrehaloseDrug

    Trehalose will be given at a dose of 10g mixed in 500 mL of water to be consumed 1 time per day for 14 days

  • PlaceboDrug

    Microcrystalline cellulose will be given at a dose of 10g mixed in 500 mL of water to be consumed 1 time per day for 14 days

Study groups in NCT05593549
Study groupRoleWhat they receive
TrehaloseExperimental10g mixed in 500 mL of water, consumed 1 time per day
Receives: Drug: Trehalose
PlaceboPlacebo comparator10g microcrystalline cellulose in 500 mL, consumed 1 time per day
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis

    Cutaneous microvascular function measured via laser Doppler flowmetry coupled with intradermal microdialysis of non-specific nitric oxide synthase inhibitor, L-NAME

    Measured: 2 weeks

  2. Autophagic Flux Protein Expression

    Autophagic Flux protein expression in Peripheral Blood Mononuclear Cells (PBMC) will be measured via exogenous treatment of PBMCs with a lysosomal inhibitor and then expression of autophagic markers will be assessed via Western Blot.

    Measured: 2 weeks

Secondary outcomes (1)
  1. Blood Pressure

    Brachial Blood Pressure

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2022
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to either active or placebo supplementation, acting as their own control.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05593549
Sponsor's protocol ID
Autophagy and Type 2 Diabetes
Status last verified
Oct 2025
First submitted
18 Oct 2022
Last updated
30 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Trehalose in people with Type 2 Diabetes and Healthy Aging, 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 0 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 30 Oct 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact William Hughes, Ph.D. (414-955-7519, whughes@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis (time frame: 2 weeks). 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 30 Oct 2025.

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