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
Verified date | August 2023 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Greece | University General Hospital AHEPA | Thessaloníki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
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 |
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