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

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Completed
• CT.gov ID: NCT05984771
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.6
• Patients Per Site Per Month: 4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathies; Diabetes Mellitus; Dietary Supplement	Dietary Supplement: Epineuron; Other: Placebo group	N/A

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

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: pilot studypilot study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: The investigator and examiner did not know the type of drug provided
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 10, 2021
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active group 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	Dietary Supplement: Epineuron; 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 Comparator: Placebo usual care	Other: Placebo group; Usual care

Outcome Measures

Primary Outcome Measures

1. Nerve conduction study to measure the velocity of the nerve impulse in the sural nerve [6 months]

   Measurement of nerve conduction velocity with Neurometrix Diabetic Peripheral Neuropathy scan device

2. Measurement of individual Vibration Perception Threshold to study vibration perception in the feet [6 months]

   Measurement of vibration perception threshold with Biothesiometer

3. Michigan Screening Neuropathy Questionnaire and Examination [6 months]

   use of michigan screening questionnaire and examination

4. Measurement of electrochemical skin conductance [6 months]

   measurement with Sudoscan the electrochemical skin conductance in hands and feet

Secondary Outcome Measures

1. Glycated Hemoglobin [6 months]

   Measurement of Glycated Hemoglobin

2. vitamin B12 levels [6 months]

   measurement of B12 levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University General Hospital AHEPA	Thessaloníki	Thessaloniki	Greece	54621

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Triantafyllos Didangelos, Professor of Internal Medicine and Diabetology, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT05984771
• Other Study ID Numbers: 54230/12.12.2020
• First Posted: Aug 9, 2023
• Last Update Posted: Aug 9, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof. Triantafyllos Didangelos, Professor of Internal Medicine and Diabetology, Aristotle University Of Thessaloniki: diabetes mellitus; neuropathy; pain
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Diabetes Mellitus

Study Results

No Results Posted as of Aug 9, 2023