RightFit
RecruitingEarly Phase 1

Role of Autophagy in Type 2 Diabetes Microvascular Dysfunction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 days, 2 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Following the first study day participants will undergo either supplementation with trehalose, an autophagy activator, or placebo for 14 days."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: Participants must be between 18-80 yrs. of age and will be delineated into two groups * 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 Exclusion Criteria: * 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) * 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

Study sites (1)

WI