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Efficacy and Safety of the Combination of Ten Elements for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study

Primary Purpose

Diabetic Neuropathies, Diabetes Mellitus, Dietary Supplement

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Epineuron
Placebo group
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring diabetes mellitus, neuropathy, pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: on metformin therapy for at least 4 years diabetes mellitus type 2 with diabetic neuropathy painful neuropathy Exclusion Criteria: healthy without diabetic neuropathy pregant

Sites / Locations

  • University General Hospital AHEPA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active group

Placebo

Arm Description

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

usual care

Outcomes

Primary Outcome Measures

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
Measurement of individual Vibration Perception Threshold to study vibration perception in the feet
Measurement of vibration perception threshold with Biothesiometer
Michigan Screening Neuropathy Questionnaire and Examination
use of michigan screening questionnaire and examination
Measurement of electrochemical skin conductance
measurement with Sudoscan the electrochemical skin conductance in hands and feet

Secondary Outcome Measures

Glycated Hemoglobin
Measurement of Glycated Hemoglobin
vitamin B12 levels
measurement of B12 levels

Full Information

First Posted
June 26, 2023
Last Updated
August 8, 2023
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT05984771
Brief Title
Efficacy and Safety of the Combination of Ten Elements for 6 Months in Patients With Diabetic Neuropathy : A Pilot 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies, Diabetes Mellitus, Dietary Supplement
Keywords
diabetes mellitus, neuropathy, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pilot study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The investigator and examiner did not know the type of drug provided
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
usual care
Intervention Type
Dietary Supplement
Intervention Name(s)
Epineuron
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Placebo group
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Nerve conduction study to measure the velocity of the nerve impulse in the sural nerve
Description
Measurement of nerve conduction velocity with Neurometrix Diabetic Peripheral Neuropathy scan device
Time Frame
6 months
Title
Measurement of individual Vibration Perception Threshold to study vibration perception in the feet
Description
Measurement of vibration perception threshold with Biothesiometer
Time Frame
6 months
Title
Michigan Screening Neuropathy Questionnaire and Examination
Description
use of michigan screening questionnaire and examination
Time Frame
6 months
Title
Measurement of electrochemical skin conductance
Description
measurement with Sudoscan the electrochemical skin conductance in hands and feet
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Glycated Hemoglobin
Description
Measurement of Glycated Hemoglobin
Time Frame
6 months
Title
vitamin B12 levels
Description
measurement of B12 levels
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: on metformin therapy for at least 4 years diabetes mellitus type 2 with diabetic neuropathy painful neuropathy Exclusion Criteria: healthy without diabetic neuropathy pregant
Facility Information:
Facility Name
University General Hospital AHEPA
City
Thessaloníki
State/Province
Thessaloniki
ZIP/Postal Code
54621
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of the Combination of Ten Elements for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study

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