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

Not Applicable

Completed

• Conditions: Diabetic Neuropathies; Dietary Supplement; Diabetes Mellitus
• Interventions: Other: Placebo group; Dietary Supplement: Epineuron

• Registration Number: NCT05984771
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2021-01-10
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Study First Submitted: 2023-06-26
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-08
• Last Update Submitted: 2023-08-08
• Study First Posted: 2023-08-09
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo group	usual care
Active group	Epineuron	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

Primary Outcome Measures

Name	Time	Method
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
Michigan Screening Neuropathy Questionnaire and Examination	6 months	use of michigan screening questionnaire and examination
Measurement of individual Vibration Perception Threshold to study vibration perception in the feet	6 months	Measurement of vibration perception threshold with Biothesiometer
Measurement of electrochemical skin conductance	6 months	measurement with Sudoscan the electrochemical skin conductance in hands and feet

Secondary Outcome Measures

Name	Time	Method
vitamin B12 levels	6 months	measurement of B12 levels
Glycated Hemoglobin	6 months	Measurement of Glycated Hemoglobin

Trial Locations

Locations (1)

University General Hospital AHEPA; 🇬🇷 Thessaloníki, Thessaloniki, Greece