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Autophagy Activator for Type 2 Diabetes
Phase < 1
Recruiting
Led By William Hughes, Ph.D.
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical Diagnosis of Type 2 Diabetes Mellitus in accordance with American Diabetes Association (ADA) guidelines (Type 2 Diabetic group)
Participants must be between 18-80 yrs. of age and will be delineated into two groups
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial seeks to understand how diabetes affects blood vessel function and if an autophagy activator can help. Participants will have 2 study days and take either a placebo or activator.
Who is the study for?
Adults aged 18-80 with Type 2 Diabetes as per ADA guidelines or healthy individuals with no more than one cardiovascular risk factor can join. Exclusions include those on erectile dysfunction meds, steroids, or hormone therapies recently; heart failure patients; BMI over 35; tobacco users in the last six months; and several other conditions.Check my eligibility
What is being tested?
This study is testing if trehalose, a sugar that may activate autophagy (cellular cleanup), improves blood vessel function in people with Type 2 Diabetes compared to a placebo. Participants will have their microvascular function tested before and after two weeks of taking either trehalose or placebo.See study design
What are the potential side effects?
While not explicitly listed for this trial, potential side effects from trehalose could include digestive issues like bloating or nausea since it's a type of sugar. Placebos typically have no active ingredients but can cause side effects based on the individual's expectations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 2 Diabetes following ADA guidelines.
Select...
I am between 18 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Autophagic Flux Protein Expression
Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis
Secondary outcome measures
Blood Pressure
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TrehaloseExperimental Treatment1 Intervention
10g mixed in 500 mL of water, consumed 1 time per day
Group II: PlaceboPlacebo Group1 Intervention
10g microcrystalline cellulose in 500 mL, consumed 1 time per day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trehalose
2016
Completed Phase 3
~100
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,523 Total Patients Enrolled
William Hughes, Ph.D.Principal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have kidney problems.I have Type 1 Diabetes.I have been diagnosed with Type 2 Diabetes following ADA guidelines.I am generally healthy with no more than one risk for heart disease.I have a history of retinopathy.I have high cholesterol.I have used steroids, either as a cream or pill, in the last 6 months.I am between 18 and 80 years old.I am currently on hormone replacement therapy.You have used tobacco in the last 6 months.I am currently taking blood thinners or anti-platelet medications.I have symptoms of heart disease.I have a condition where my skin blisters in the sun.I have had COVID-19 within the last 3 months.Undergoing gender transition therapy.I have heart failure.You are allergic to povidone iodine.My high blood pressure is not under control.I am not pregnant.I have high cholesterol.I have a diagnosed neuromuscular disorder.My BMI is over 35.I have used medication for erectile dysfunction in the last 6 months.I am currently on cancer treatment or was treated within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Trehalose
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatric patients eligible for enrollment in this experiment?
"This research is open to adult participants who are 18 years or older and below the age 80."
Answered by AI
Are there any eligibility criteria for participants in this clinical experiment?
"The aim of this medical investigation is to recruit 60 individuals with Type 2 diabetes that are aged between 18 and 80. Specifically, the American Diabetes Association's criteria for Type 2 diabetes must be fulfilled in order to qualify for study involvement."
Answered by AI
Are there open slots in this trial for participants?
"Affirmative. Clinicaltrials.gov reveals that this trial is appending new participants, which was initially posted on January 1st 2023. Subsequent updates were made March 13th of the same year and it requires 60 volunteers to be recruited from a single medical center."
Answered by AI
What is the current size of this research project's participant pool?
"Affirmative. Clinicaltrials.gov data suggests that this research trial, which was first put up on January 1st 2023, is actively seeking participants. Approximately 60 patients must be admitted from one medical centre."
Answered by AI
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