Diabetic NeuropathiesNCT05984771
Efficacy and Safety of the Combination of Ten Elements for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study
A study testing Epineuron in people with Diabetic Neuropathies and Diabetes Mellitus, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Diabetic Neuropathies, Diabetes Mellitus, Dietary Supplement
- What is being tested?
- Epineuron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- on metformin therapy for at least 4 years
- diabetes mellitus type 2 with diabetic neuropathy
- painful neuropathy
Who cannot join
- healthy
- without diabetic neuropathy
- pregant
Trial locations and contacts
1 site in 1 country.
Greece1 site
University General Hospital AHEPA
Thessaloniki, Thessaloniki, 54621
About this study
Official title: Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamins B12, B1, B2, B6, E, Mg, Zn and Palmitoylethanolamide for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study
To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN).
Read the detailed description
To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN).
Patients - methods: In this pilot study, 61 patients with Diabetes Mellitus Type 2 (DMT2, 31 women), with mean duration of DM 17.5 years and mean age 63 years were randomly assigned, either to receive the combination of ten elements (2 tablets/24h) in the active group, (n=30), or the placebo (n=31) for 6 months. We used Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured vibration perception threshold (VPT) and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Sudomotor function was assessed with SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF). Pain (PS) questionnaire was administered, also. All patients received metformin for at least 4 years.
- Conditions
- Diabetic Neuropathies, Diabetes Mellitus, Dietary Supplement
- Being tested
- Epineuron, Placebo group
- Keywords
- diabetes mellitus, neuropathy, pain
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpineuronDietary supplement
Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet (Epineuron)
Placebo groupOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | 10-element combination tablet (n=30) Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet for 6 months Receives: Dietary Supplement: Epineuron |
| Placebo | Placebo comparator | usual care Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve conduction study to measure the velocity of the nerve impulse in the sural nerve
Measurement of nerve conduction velocity with Neurometrix Diabetic Peripheral Neuropathy scan device
Measured: 6 months
Measurement of individual Vibration Perception Threshold to study vibration perception in the feet
Measurement of vibration perception threshold with Biothesiometer
Measured: 6 months
Michigan Screening Neuropathy Questionnaire and Examination
use of michigan screening questionnaire and examination
Measured: 6 months
Measurement of electrochemical skin conductance
measurement with Sudoscan the electrochemical skin conductance in hands and feet
Measured: 6 months
Secondary outcomes (2)
Glycated Hemoglobin
Measurement of Glycated Hemoglobin
Measured: 6 months
vitamin B12 levels
measurement of B12 levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start10 Jan 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Triantafyllos Didangelos, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984771
- Sponsor's protocol ID
- 54230/12.12.2020
- Status last verified
- Aug 2023
- First submitted
- 26 Jun 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamins B12, B1, B2, B6, E, Mg, Zn and Palmitoylethanolamide for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study
- ClinicalTrials.gov ID
- NCT05984771
- Acronym / sponsor ID
- 54230/12.12.2020
- Conditions
- Diabetic Neuropathies, Diabetes Mellitus, Dietary Supplement
- Keywords
- diabetes mellitus, neuropathy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN).
Detailed description
To investigate the efficacy of Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet in patients with Diabetic Neuropathy (DN).
Patients - methods: In this pilot study, 61 patients with Diabetes Mellitus Type 2 (DMT2, 31 women), with mean duration of DM 17.5 years and mean age 63 years were randomly assigned, either to receive the combination of ten elements (2 tablets/24h) in the active group, (n=30), or the placebo (n=31) for 6 months. We used Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured vibration perception threshold (VPT) and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Sudomotor function was assessed with SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF). Pain (PS) questionnaire was administered, also. All patients received metformin for at least 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- pilot study
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Dietary Supplement: Epineuron10-element combination tablet (n=30) Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet for 6 months |
| Placebo | Placebo comparator | Other: Placebo groupusual care |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- on metformin therapy for at least 4 years
- diabetes mellitus type 2 with diabetic neuropathy
- painful neuropathy
Key exclusion criteria (3 listed)
- healthy
- without diabetic neuropathy
- pregant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpineuronSuperoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet (Epineuron) | Dietary supplement | Active group |
| Placebo groupUsual care | Other | Placebo |
Primary outcome
Nerve conduction study to measure the velocity of the nerve impulse in the sural nerve
Time frame: 6 months
Measurement of nerve conduction velocity with Neurometrix Diabetic Peripheral Neuropathy scan device
Measurement of individual Vibration Perception Threshold to study vibration perception in the feet
Time frame: 6 months
Measurement of vibration perception threshold with Biothesiometer
Michigan Screening Neuropathy Questionnaire and Examination
Time frame: 6 months
use of michigan screening questionnaire and examination
Measurement of electrochemical skin conductance
Time frame: 6 months
measurement with Sudoscan the electrochemical skin conductance in hands and feet
2 secondary outcomes
Glycated Hemoglobin
Time frame: 6 months
vitamin B12 levels
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epineuron in people with Diabetic Neuropathies and Diabetes Mellitus, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction study to measure the velocity of the nerve impulse in the sural nerve (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.