RecruitingPhase 2ACTRN12624000623594

Efficacy of a ubiquinone based combination therapy in reducing pain in people with diabetes-related painful peripheral neuropathy.

Efficacy of mitochondrial combination therapy in addressing pain intensity and nerve function in Type 2 Diabetes-Related Painful Peripheral Neuropathy: the Mito-T2D-PPN study


Sponsor

Melbourne Health/Royal Melbourne Hospital

Enrollment

124 participants

Start Date

Jun 7, 2024

Study Type

Interventional

Conditions

Summary

To determine if a combination mitochondrial-based therapy using over-the-counter supplements can result in an improvement in the sensation of nerve-related pain in people with diabetes-related painful peripheral neuropathy.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Diabetic peripheral neuropathy is a common and often painful complication of type 2 diabetes, where the nerves — especially in the feet and legs — become damaged due to high blood sugar levels over time. The burning, stabbing, or shooting pain it causes can be severe and difficult to treat with standard medications. This study is investigating whether a combination of over-the-counter supplements targeting how cells produce energy (mitochondrial function) can reduce this nerve pain. The supplements being tested are known to support the energy-producing parts of cells (mitochondria), which are thought to play a role in nerve damage in diabetes. Participants will take the supplement combination for a defined period and report their pain levels using a validated questionnaire before and after treatment. You may be eligible if you are an adult aged 18 or older who has been diagnosed with type 2 diabetes as an adult and has diabetes-related painful nerve damage confirmed by a standardised screening tool. People with active foot ulcers, severe kidney disease, liver cirrhosis, blood clotting disorders, or current pregnancy are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

For this combination mitochondrial-based therapy, one tablet of each of four over-the-counter supplements (or placebo) will be taken orally, once daily, for 16 weeks. The supplements may include: Coen

For this combination mitochondrial-based therapy, one tablet of each of four over-the-counter supplements (or placebo) will be taken orally, once daily, for 16 weeks. The supplements may include: Coenzyme Q10, magnesium, alpha-lipoic acid and thiamine. Adherence will be monitored through study medication diary and medication capsule return.


Locations(2)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

St Vincent's Private Hospital - Fitzroy

VIC, Australia

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ACTRN12624000623594