Clinical trial NCT05984771: Efficacy and Safety of the Combination of Ten Elements for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Diabetes Mellitus
Dietary Supplement
Keywords: diabetes mellitus
neuropathy
pain
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nerve conduction study to measure the velocity of the nerve impulse in the sural nerve
timeFrame: 6 months
measure: Measurement of individual Vibration Perception Threshold to study vibration perception in the feet
timeFrame: 6 months
measure: Michigan Screening Neuropathy Questionnaire and Examination
timeFrame: 6 months
measure: Measurement of electrochemical skin conductance
timeFrame: 6 months
Secondary outcomes:
measure: Glycated Hemoglobin
timeFrame: 6 months
measure: vitamin B12 levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: University General Hospital AHEPA
state: Thessaloniki
Study officials:
References: