60 Participants Needed

Autophagy Activator for Type 2 Diabetes

WH
Overseen ByWilliam Hughes, Ph.D.

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain drugs like anti-coagulants, anti-platelet drugs, or steroids. It's best to discuss your specific medications with the trial coordinators.

What evidence supports the effectiveness of the drug trehalose for treating type 2 diabetes?

Research shows that trehalose can activate autophagy (a process where cells clean out damaged components) and reduce blood sugar levels in diabetic mice, suggesting it may help manage type 2 diabetes.12345

Is trehalose safe for human use?

Trehalose, a natural sugar, has been used widely as a food additive and preservative with minimal toxicity reported. Studies show it can activate autophagy (a process that cleans out damaged cells) and has been used safely in various research contexts, including diabetes and liver conditions.12456

How does the drug trehalose work for type 2 diabetes?

Trehalose is unique because it activates autophagy (a process that cleans out damaged cells) without affecting mTOR (a protein that regulates cell growth), which is different from many other diabetes treatments. It also helps reduce blood sugar levels and inflammation, making it a promising option for managing type 2 diabetes.12357

What is the purpose of this trial?

This trial tests whether a sugar called trehalose can help improve small blood vessel function in adults with Type 2 Diabetes. Participants will take trehalose for a short period. Trehalose helps cells clean out damaged parts, which may help blood vessels relax and widen more easily. Trehalose is a naturally occurring disaccharide that has been found to improve glucose metabolism and homeostasis in different diabetes models.

Research Team

WH

William Hughes, Ph.D.

Principal Investigator

Medical College of Wisconsin

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes following ADA guidelines.
I am generally healthy with no more than one risk for heart disease.

Exclusion Criteria

I have kidney problems.
I have Type 1 Diabetes.
I have a history of retinopathy.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either trehalose or placebo for 14 days to assess the role of autophagy in microvascular function

2 weeks
2 study days (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • Placebo
  • Trehalose
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Findings from Research

Trehalose, a natural compound, effectively induces autophagy in neural stem cells and is as potent as rapamycin and starvation in promoting autophagosome formation, which is crucial for cellular health.
In conditions of high glucose and maternal diabetes, trehalose not only reverses the suppression of autophagy but also enhances the removal of damaged organelles, suggesting its therapeutic potential in preventing autophagy-related disorders.
Trehalose restores functional autophagy suppressed by high glucose.Xu, C., Chen, X., Sheng, WB., et al.[2020]
Trehalose, a natural disaccharide, promotes cellular autophagy by inhibiting glucose transport through the SLC2A (GLUT) family of glucose transporters, which may help in treating diseases related to protein aggregation.
In animal studies, trehalose reduced liver fat (hepatic steatosis) and decreased lipid droplet accumulation in liver cells, suggesting its potential as a therapeutic agent for metabolic disorders.
Trehalose inhibits solute carrier 2A (SLC2A) proteins to induce autophagy and prevent hepatic steatosis.DeBosch, BJ., Heitmeier, MR., Mayer, AL., et al.[2018]
Trehalose is a promising autophagy inducer with minimal side effects, approved for human use, that shows potential in treating neurodegenerative diseases by reducing neurotoxic protein accumulation and enhancing antioxidant defenses.
In animal models of Alzheimer's, Parkinson's, and Huntington's diseases, trehalose demonstrated neuroprotective effects, suggesting it could be an effective multitarget therapy for neurodegeneration, warranting further clinical investigation.
Disaccharide trehalose in experimental therapies for neurodegenerative disorders: Molecular targets and translational potential.Pupyshev, AB., Klyushnik, TP., Akopyan, AA., et al.[2022]

References

Trehalose restores functional autophagy suppressed by high glucose. [2020]
Trehalose inhibits solute carrier 2A (SLC2A) proteins to induce autophagy and prevent hepatic steatosis. [2018]
Disaccharide trehalose in experimental therapies for neurodegenerative disorders: Molecular targets and translational potential. [2022]
Using trehalose to prevent and treat metabolic function: effectiveness and mechanisms. [2022]
Trehalose Activates Hepatic and Myocardial Autophagy and Has Anti-Inflammatory Effects in db/db Diabetic Mice. [2022]
Sweet taste receptor agonists attenuate macrophage IL-1β expression and eosinophilic inflammation linked to autophagy deficiency in myeloid cells. [2022]
Trehalose, sucrose and raffinose are novel activators of autophagy in human keratinocytes through an mTOR-independent pathway. [2022]
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