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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05984771
• Other study ID #: 54230/12.12.2020
• Status: Completed
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2023
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Dietary Supplement
• Peripheral Nervous System Diseases

Intervention

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)

Other:
• Placebo group
Usual care

Locations

Country	Name	City	State
Greece	University General Hospital AHEPA	Thessaloníki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Measurement of individual Vibration Perception Threshold to study vibration perception in the feet	Measurement of vibration perception threshold with Biothesiometer	6 months
Primary	Michigan Screening Neuropathy Questionnaire and Examination	use of michigan screening questionnaire and examination	6 months
Primary	Measurement of electrochemical skin conductance	measurement with Sudoscan the electrochemical skin conductance in hands and feet	6 months
Secondary	Glycated Hemoglobin	Measurement of Glycated Hemoglobin	6 months
Secondary	vitamin B12 levels	measurement of B12 levels	6 months