Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction

NCT05593549 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: Autophagy and Type 2 Diabetes
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes; Healthy Aging

Keywords

autophagy; microvascular function; laser doppler microdialysis

Outcome Measures

Primary Outcomes (2)

• 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

  2 weeks

• 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.

  2 weeks

Secondary Outcomes (1)

• Blood Pressure

  2 weeks

Study Arms (2)

Trehalose

EXPERIMENTAL

10g mixed in 500 mL of water, consumed 1 time per day

Drug: Trehalose

Placebo

PLACEBO COMPARATOR

10g microcrystalline cellulose in 500 mL, consumed 1 time per day

Drug: Placebo

Interventions

Trehalose DRUG

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

Trehalose

Placebo DRUG

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

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:

• Clinical Diagnosis of Type 2 Diabetes Mellitus in accordance with American Diabetes Association (ADA) guidelines (Type 2 Diabetic group)
• Otherwise healthy individuals (Healthy control group) with no more than 1 cardiovascular risk factor

You may not qualify if:

• Uncontrolled hypertension
• Current Tobacco use or within last 6 months
• BMI \> 35
• Hyperlipidemia
• Hypercholesterolemia
• Type 1 Diabetes
• 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)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Trehalose

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Officials

• William Hughes, Ph.D.

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Hughes, Ph.D.

CONTACT

414-955-7519; whughes@mcw.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 25, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)