Vitamin B12 Supplementation in Diabetic Neuropathy: A 1-Year, Randomized, Double-Blind, Placebo-Controlled Trial
| Autor: | Triantafyllos Didangelos, Parthena Giannoulaki, Georgios Batanis, Solomon Tesfaye, Eleni Margariti, Evangelia Kotzakioulafi, Eleni Karlafti, Kοnstantinos Kantartzis |
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| Rok vydání: | 2021 |
| Předmět: |
Male
Diabetic neuropathy Placebo-controlled study 030204 cardiovascular system & hematology Nerve conduction velocity Orthostatic vital signs 0302 clinical medicine Diabetic Neuropathies polycyclic compounds Prospective Studies SUDOSCAN Nutrition and Dietetics vitamin B12 Middle Aged diabetic neuropathy Vitamin B 12 Cholesterol Creatinine Anesthesia diabetes mellitus Female lcsh:Nutrition. Foods and food supply diabetic foot medicine.drug lcsh:TX341-641 030209 endocrinology & metabolism Placebo Article 03 medical and health sciences Vibration perception Folic Acid Double-Blind Method painful neuropathy medicine Autonomic reflex Humans Hypoglycemic Agents Autonomic Neuropathy Diabetes Mellitus Diabetic Foot Diabetic Neuropathy Metformin Painful Neuropathy Sudoscan Vitamin B12 Triglycerides Glycated Hemoglobin business.industry nutritional and metabolic diseases medicine.disease Diabetes Mellitus Type 2 Dietary Supplements Methylcobalamin Linear Models Quality of Life metformin business autonomic neuropathy Follow-Up Studies Food Science |
| Zdroj: | Nutrients Nutrients 13:395 (2021) Nutrients, Vol 13, Iss 395, p 395 (2021) Volume 13 Issue 2 |
| ISSN: | 2072-6643 |
| DOI: | 10.3390/nu13020395 |
| Popis: | Aim: To investigate the effect of normalizing vitamin B12 (B12) levels with oral B12 (methylcobalamin) 1000 &mu g/day for one year in patients with diabetic neuropathy (DN). Patients and methods: In this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin for at least four years and both peripheral and autonomic DN were randomized to an active treatment group (n = 44) receiving B12 and a control group (n = 46) receiving a placebo. All patients had B12 levels less than 400 pmol/L. Subjects underwent measurements of sural nerve conduction velocity (SNCV), sural nerve action potential (amplitude) (SNAP), and vibration perception threshold (VPT), and they performed cardiovascular autonomic reflex tests (CARTs: mean circular resultant (MCR), Valsalva test, postural index, and orthostatic hypotension). Sudomotor function was assessed with the SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF, respectively). We also used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE, respectively) and questionnaires to evaluate quality of life (QoL) and level of pain (pain score). Results: B12 levels increased from 232.0 ± 71.8 at baseline to 776.7 ± 242.3 pmol/L at follow-up, p < 0.0001, in the active group but not in the control group. VPT, MNSIQ, QoL, pain score, SNCV, SNAP, and ESCF significantly improved in the active group (p < 0.001, p = 0.002, p < 0.0001, p < 0.000, p < 0.0001, and p = 0.014, respectively), whereas CARTS and MNSIE improved but not significantly. MCR, MNSIQ, SNCV, SNAP, and pain score significantly deteriorated in the control group (p = 0.025, p = 0.017, p = 0.045, p < 0.0001, and p < 0.0001, respectively). Conclusions: The treatment of patients with DN with 1 mg of oral methylcobalamin for twelve months increased plasma B12 levels and improved all neurophysiological parameters, sudomotor function, pain score, and QoL, but it did not improve CARTS and MNSIE. |
| Databáze: | OpenAIRE |
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