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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12624000623594
Ethics application status
Approved
Date submitted
8/04/2024
Date registered
14/05/2024
Date last updated
14/05/2024
Date data sharing statement initially provided
14/05/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy of a ubiquinone based combination therapy in reducing pain in people with diabetes-related painful peripheral neuropathy.
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Scientific title
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
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Secondary ID [1]
309440
0
Nil known
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Universal Trial Number (UTN)
U1111-1291-1820
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Trial acronym
Mito-T2D_PPN study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
diabetes mellitus
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Type 2 diabetes
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painful peripheral neuropathy
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mitochondrial dysfunction
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Condition category
Condition code
Alternative and Complementary Medicine
326593
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0
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Other alternative and complementary medicine
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Metabolic and Endocrine
326594
326594
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0
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Diabetes
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Neurological
326595
326595
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
325922
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Treatment: Drugs
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Comparator / control treatment
partially pregelatinized starch capsule
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Participant sense of pain intensity as assessed by the short form McGill Pain Questionnaire (SF-MPQ)
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Assessment method [1]
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Timepoint [1]
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Baseline and 16 weeks post-intervention commencement
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Primary outcome [2]
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Participant measurement of nerve function as assessed by nerve conduction study
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Assessment method [2]
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Timepoint [2]
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Baseline and week 16 (end of study) post-intervention commencement
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Primary outcome [3]
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Participant quality of life as assessed by the Medical Outcomes Survey Short Form 36 (MOS SF36) Quality of Life Questionnaire
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Assessment method [3]
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Timepoint [3]
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Baseline and week 16 (end of study) post-intervention commencement
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Secondary outcome [1]
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Safety will be assessed by the incidence of adverse events including but not limited to nausea assessed by self-report study diary, muscle pain assessed by self-report study-specific questionnaire, and dizziness assessed by self-report study diary
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Assessment method [1]
421023
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Timepoint [1]
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Baseline, 8 and 16 weeks post-intervention commencement
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Eligibility
Key inclusion criteria
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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involve contacting the holder of the allocation schedule who is at the central clinical trial pharmacy site
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Analysis of primary outcome will involve a logistic regression model with absence or presence of favourable outcome as the dependent variable, treatment as an independent variable, and baseline value of visual analogue score (VAS) as a treatment co-variate. Data will be presented as median and interquartile range. The Mann-Whitney U-test will be applied for unpaired data analyses.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/05/2024
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Actual
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Date of last participant enrolment
Anticipated
2/06/2025
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Actual
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Date of last data collection
Anticipated
8/12/2025
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Actual
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Sample size
Target
124
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [2]
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St Vincent's Private Hospital - Fitzroy
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Recruitment postcode(s) [1]
42535
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3050 - Parkville
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Recruitment postcode(s) [2]
42536
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3065 - Fitzroy
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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ACADI (Australian Centre for Accelerating Diabetes Innovations)
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Address [1]
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University of MelbourneRoyal ParadeParkville VIC 3050
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Melbourne Health/Royal Melbourne Hospital
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Address
300 Grattan StreetParkville VIC 3050
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
315429
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Country [1]
315429
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Melbourne Hospital Human Research Ethics Committee
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Ethics committee address [1]
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Office for ResearchRoyal Melbourne Hospital300 Grattan StreetParkville VIC 3050
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/04/2023
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Approval date [1]
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20/07/2023
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Ethics approval number [1]
312805
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Summary
Brief 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Spiros Fourlanos
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Address
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Department of Diabetes and EndocrinologyRoyal Melbourne Hospital300 Grattan StreetParkville VIC 3050
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Country
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Australia
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Phone
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+61 393427365
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Fax
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+61 393427278
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Spiros Fourlanos
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Address
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Department of Diabetes and EndocrinologyRoyal Melbourne Hospital300 Grattan StreetParkville VIC 3050
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Country
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Australia
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Phone
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+61 393427365
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Fax
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+61 393427278
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Spiros Fourlanos
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Address
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Department of Diabetes and EndocrinologyRoyal Melbourne Hospital300 Grattan StreetParkville VIC 3050
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Country
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Australia
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Phone
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+61 393427365
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Fax
125988
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+61393427278
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all of the individual de-identified participant data collected during the trial
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When will data be available (start and end dates)?
Immediately following publication and with no end date determined
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Available to whom?
case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
for IPD meta-analyses
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How or where can data be obtained?
access subject to approvals by Principal Investigator (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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