What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes, such as GLP-1 receptor agonists (e.g., exenatide, liraglutide), DPP-4 inhibitors (e.g., trelagliptin), and SGLT2 inhibitors (e.g., dapagliflozin), have various side effects. GLP-1 receptor agonists often cause gastrointestinal issues like nausea and vomiting. DPP-4 inhibitors are generally well-tolerated but can cause mild to moderate adverse events. SGLT2 inhibitors may lead to urinary tract infections and, in some cases, increased risk of amputations. Traditional therapies like insulin can cause hypoglycemia, while secretagogues may also lead to weight gain and hypoglycemia. Trehalose, an autophagy activator, is still under study, but potential side effects could include gastrointestinal discomfort.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes, including GLP-1 receptor agonists such as liraglutide and extended-release exenatide for children aged 10 years and older. Liraglutide has shown efficacy in improving glycemic control and modest weight loss, while extended-release exenatide has demonstrated significant improvements in glycemic control. Additionally, dulaglutide has been approved for its efficacy in glycemic control in pediatric patients. While these treatments do not directly relate to autophagy activation like Trehalose, they represent significant advancements in the pharmacological management of Type 2 Diabetes.

What other types of research exist?

Promising alternatives to Trehalose for Type 2 Diabetes patients include: <ol> <li>GLP-1 receptor agonists (e.g., liraglutide, semaglutide, dulaglutide) - These have shown significant improvements in glycemic control and cardiovascular outcomes.</li> <li></li> </ol> SGLT2 inhibitors (e.g., empagliflozin, canagliflozin, dapagliflozin) - These drugs improve glycemic control and have demonstrated cardiovascular and renal benefits. 3. Metformin - While not novel, it remains a cornerstone of diabetes treatment and has shown potential benefits in autophagy activation. 4. Rapamycin - This has shown promise in preclinical studies for its effects on autophagy and may be considered for further research in diabetes management.

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Autophagy Activator for Type 2 Diabetes

Q: What is the mechanism of action of this treatment?

Common treatments for Type 2 Diabetes include metformin, which reduces hepatic glucose production and improves insulin sensitivity; sulfonylureas and meglitinides, which increase insulin secretion from the pancreas; and SGLT2 inhibitors, which reduce glucose reabsorption in the kidneys. GLP-1 receptor agonists enhance insulin secretion and inhibit glucagon release, while DPP-4 inhibitors prolong the action of incretin hormones. Autophagy activators like Trehalose, being studied for their potential to improve microvascular function, may offer a novel approach by enhancing cellular cleanup processes, which could mitigate some complications of diabetes. Understanding these mechanisms helps tailor treatment to individual patient needs, improving glycemic control and reducing the risk of complications.

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

Must not have

Type 1 Diabetes

History of Retinopathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Summary

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.

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.

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.

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 below

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I have been diagnosed with Type 2 Diabetes following ADA guidelines.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have Type 1 Diabetes.

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I have a history of retinopathy.

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I am currently on hormone replacement therapy.

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I am currently taking blood thinners or anti-platelet medications.

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I have symptoms of heart disease.

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I have a condition where my skin blisters in the sun.

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I have had COVID-19 within the last 3 months.

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I have heart failure.

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My high blood pressure is not under control.

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I am not pregnant.

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I have a diagnosed neuromuscular disorder.

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My BMI is over 35.

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I have used medication for erectile dysfunction in the last 6 months.

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I am currently on cancer treatment or was treated within the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Autophagic Flux Protein Expression

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

Secondary study objectives

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

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include metformin, which reduces hepatic glucose production and improves insulin sensitivity; sulfonylureas and meglitinides, which increase insulin secretion from the pancreas; and SGLT2 inhibitors, which reduce glucose reabsorption in the kidneys. GLP-1 receptor agonists enhance insulin secretion and inhibit glucagon release, while DPP-4 inhibitors prolong the action of incretin hormones. Autophagy activators like Trehalose, being studied for their potential to improve microvascular function, may offer a novel approach by enhancing cellular cleanup processes, which could mitigate some complications of diabetes. Understanding these mechanisms helps tailor treatment to individual patient needs, improving glycemic control and reducing the risk of complications.

Safety and efficacy of once weekly dipeptidyl-peptidase-4 inhibitor trelagliptin in type-2 diabetes: A meta-analysis.Key considerations in pharmacotherapy for type 2 diabetes mellitus: a multiple target organ approach.Overcoming obstacles in risk factor management in type 2 diabetes mellitus.