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
Melbourne Health/Royal Melbourne Hospital
124 participants
Jun 7, 2024
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
Inclusion Criteria1
- Adults aged 18 years or greater who have been diagnosed with type 2 diabetes (according to WHO criteria) in adulthood and have diabetes-related painful peripheral neuropathy as confirmed with the Michigan Neuropathy Screening Instrument (MNSI)
Exclusion Criteria1
- Active foot ulcer and/or infections, eGFR <30ml/min/1.73m2 (as calculated by the CKD-EPI creatinine formula), cirrhosis of the liver, bleeding disorders or use of oral anticoagulant medications, untreated active vitamin B12 deficiency, women who are lactating, pregnant or intend to become pregnant during the course of the study, cancer treated in the 12 months prior
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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: Coenzyme Q10, magnesium, alpha-lipoic acid and thiamine. Adherence will be monitored through study medication diary and medication capsule return.
Locations(2)
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ACTRN12624000623594