Diabetes Mellitus, Diabetic Neuropathies, Dietary Supplement
Conditions
Keywords
diabetes mellitus, neuropathy, pain
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.
Interventions
DIETARY_SUPPLEMENTEpineuron
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)
OTHERPlacebo group
Usual care
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The investigator and examiner did not know the type of drug provided
Intervention model description
pilot study
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of individual Vibration Perception Threshold to study vibration perception in the feet | 6 months | Measurement of vibration perception threshold with Biothesiometer |
| Michigan Screening Neuropathy Questionnaire and Examination | 6 months | use of michigan screening questionnaire and examination |
| 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 |
| Measurement of electrochemical skin conductance | 6 months | measurement with Sudoscan the electrochemical skin conductance in hands and feet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Hemoglobin | 6 months | Measurement of Glycated Hemoglobin |
| vitamin B12 levels | 6 months | measurement of B12 levels |
Countries
Greece
Outcome results
None listed