An interventional study of Epineuron and Placebo group in Diabetic Neuropathies, Diabetes Mellitus and Dietary Supplement, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to female participants. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Treatment
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).
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.
629 studies on the registry are indexed under Diabetic Neuropathies; 92 are open to participants now.
This study's enrollment of 70 is close to the median of 72 across 522 interventional studies indexed under Diabetic Neuropathies.
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Exclusion Criteria:
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
usual care
Other: Placebo group
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)
Usual care
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
Time frame: 6 months
Measurement of individual Vibration Perception Threshold to study vibration perception in the feet
Measurement of vibration perception threshold with Biothesiometer
Time frame: 6 months
Michigan Screening Neuropathy Questionnaire and Examination
use of michigan screening questionnaire and examination
Time frame: 6 months
Measurement of electrochemical skin conductance
measurement with Sudoscan the electrochemical skin conductance in hands and feet
Time frame: 6 months
Glycated Hemoglobin
Measurement of Glycated Hemoglobin
Time frame: 6 months
vitamin B12 levels
measurement of B12 levels
Time frame: 6 months
Plan to share: No
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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