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

NCT05984771 | Completed

• 1 other identifier: 54230/12.12.2020
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Dietary Supplement

Keywords

diabetes mellitus; neuropathy; pain

Outcome Measures

Primary Outcomes (4)

• 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

  6 months

• Measurement of individual Vibration Perception Threshold to study vibration perception in the feet

  Measurement of vibration perception threshold with Biothesiometer

  6 months

• Michigan Screening Neuropathy Questionnaire and Examination

  use of michigan screening questionnaire and examination

  6 months

• Measurement of electrochemical skin conductance

  measurement with Sudoscan the electrochemical skin conductance in hands and feet

  6 months

Secondary Outcomes (2)

• Glycated Hemoglobin

  6 months

• vitamin B12 levels

  6 months

Study Arms (2)

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

Dietary Supplement: Epineuron

Placebo

PLACEBO COMPARATOR

usual care

Other: Placebo group

Interventions

Epineuron DIETARY_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)

Active group

Placebo group OTHER

Usual care

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• on metformin therapy for at least 4 years
• diabetes mellitus type 2 with diabetic neuropathy
• painful neuropathy

You may not qualify if:

• healthy
• without diabetic neuropathy
• pregant

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

University General Hospital AHEPA

Thessaloniki, Thessaloniki, 54621, Greece

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and examiner did not know the type of drug provided
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine and Diabetology

Model Details: pilot study

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 9, 2023
• Study Start: January 10, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)