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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
1/09/2024
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.
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
Secondary ID [1] 309440 0
Nil known
Universal Trial Number (UTN)
U1111-1291-1820
Trial acronym
Mito-T2D_PPN study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes mellitus 329694 0
Type 2 diabetes 329695 0
painful peripheral neuropathy 329696 0
mitochondrial dysfunction 329697 0
Condition category
Condition code
Alternative and Complementary Medicine 326593 326593 0 0
Other alternative and complementary medicine
Metabolic and Endocrine 326594 326594 0 0
Diabetes
Neurological 326595 326595 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325922 0
Treatment: Drugs
Comparator / control treatment
partially pregelatinized starch capsule
Control group
Placebo

Outcomes
Primary outcome [1] 334535 0
Participant sense of pain intensity as assessed by the short form McGill Pain Questionnaire (SF-MPQ)
Timepoint [1] 334535 0
Baseline and 16 weeks post-intervention commencement
Primary outcome [2] 334536 0
Participant measurement of nerve function as assessed by nerve conduction study
Timepoint [2] 334536 0
Baseline and week 16 (end of study) post-intervention commencement
Primary outcome [3] 334537 0
Participant quality of life as assessed by the Medical Outcomes Survey Short Form 36 (MOS SF36) Quality of Life Questionnaire
Timepoint [3] 334537 0
Baseline and week 16 (end of study) post-intervention commencement
Secondary outcome [1] 421023 0
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
Timepoint [1] 421023 0
Baseline, 8 and 16 weeks post-intervention commencement

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2024
Actual
7/06/2024
Date of last participant enrolment
Anticipated
2/06/2025
Actual
Date of last data collection
Anticipated
8/12/2025
Actual
Sample size
Target
124
Accrual to date
19
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26493 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 26494 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 42535 0
3050 - Parkville
Recruitment postcode(s) [2] 42536 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 313635 0
Government body
Name [1] 313635 0
ACADI (Australian Centre for Accelerating Diabetes Innovations)
Country [1] 313635 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health/Royal Melbourne Hospital
Address
300 Grattan StreetParkville VIC 3050
Country
Australia
Secondary sponsor category [1] 315429 0
None
Name [1] 315429 0
Address [1] 315429 0
Country [1] 315429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312805 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 312805 0
Ethics committee country [1] 312805 0
Australia
Date submitted for ethics approval [1] 312805 0
26/04/2023
Approval date [1] 312805 0
20/07/2023
Ethics approval number [1] 312805 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125986 0
A/Prof Spiros Fourlanos
Address 125986 0
Department of Diabetes and EndocrinologyRoyal Melbourne Hospital300 Grattan StreetParkville VIC 3050
Country 125986 0
Australia
Phone 125986 0
+61 393427365
Fax 125986 0
+61 393427278
Email 125986 0
[email protected]
Contact person for public queries
Name 125987 0
Spiros Fourlanos
Address 125987 0
Department of Diabetes and EndocrinologyRoyal Melbourne Hospital300 Grattan StreetParkville VIC 3050
Country 125987 0
Australia
Phone 125987 0
+61 393427365
Fax 125987 0
+61 393427278
Email 125987 0
[email protected]
Contact person for scientific queries
Name 125988 0
Spiros Fourlanos
Address 125988 0
Department of Diabetes and EndocrinologyRoyal Melbourne Hospital300 Grattan StreetParkville VIC 3050
Country 125988 0
Australia
Phone 125988 0
+61 393427365
Fax 125988 0
+61393427278
Email 125988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual de-identified participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication and with no end date determined
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


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.