Diabetes Mellitus Clinical Trial
Official title:
Vitamin B12 Supplementation in Diabetic Neuropathy :1-year Double Blind Randomized Placebo-Controlled Trial
Verified date | January 2021 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective double-blind placebo-controlled trial aims to investigate the safety and efficacy of oral dispersible tablet of vitamin B12 for 1 year, in 90 patients with diabetes mellitus type 2 and neuropathy.
Status | Completed |
Enrollment | 90 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - adults (>18 years old) with Diabetes Mellitus 2 - established Diabetic neuropathy, both peripheral and autonomic (Diabetic Peripheral Neuropathy and Diabetic Autonomic Neuropathy). (Diagnosis was made with a)two or more Cardiovascular Autonomic Reflex Tests abnormal, b)abnormal nerve conduction velocity, c)abnormal Michigan Neuropathy Screening Instrument Questionnaire and Michigan Neuropathy Screening Instrument Examination ). - good glycemic control (HbA1c between 6.5 and 7.5 %), stable in the last year before participating in the study - metformin treatment for at least 4 years - low vitamin B12 levels according to suggested normal values for DM2 patients over 60 years old (<400 pmol/L) Exclusion Criteria: - pernicious anemia, - alcoholism - gastrectomy - gastric bypass surgery - pancreatic insufficiency - malabsorption syndromes - chronic giardiasis - acute infection in the last 6 months - cardiovascular event in the last 6 months - surgery involving small intestine or Human Immunodeficiency Virus infection. - Patients with estimated Glomerular Filtration Rate <50 mL/min/1.73m2 - taking multivitamins or B12 supplements in the last 12 months |
Country | Name | City | State |
---|---|---|---|
Greece | University General Hospital AHEPA | Thessaloníki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki | University Hospital Tuebingen, University of Sheffield |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Sural Nerve Function measured by conduction velocity | Sural Nerve conduction velocity measured as m/s | 12 months | |
Primary | Change in Sural Nerve Function measured by amplitude | Sural Nerve conduction amplitude measured as µV | 12 months | |
Primary | Change in Michigan Neuropathy Screening Instrument Questionnaire | Michigan Neuropathy Screening Instrument questionnaire (The Michigan Neuropathy Screening Instrument (MNSI) includes two separate assessments, a 15-item self-administered questionnaire and a lower extremity examination. the questionnaire is scored by summing abnormal responses. Responses are added to obtain a total score. 'Yes' responses to questions 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. 'No' responses to questions 7 and 13 each count as one point. Question 4 was considered to be a measure of impaired circulation and question 10 a measure of general asthenia and were not included in the published scoring algorithm. A score of = 7 was considered abnormal. | 12 months | |
Primary | Change in Michigan Neuropathy Screening Instrument Examination | Michigan Neuropathy Screening Instrument Examination (The Michigan Neuropathy Screening Instrument (MNSI) includes two separate assessments, a 15-item self-administered questionnaire that is scored by summing abnormal responses, and a lower extremity examination that includes inspection and assessment of vibratory sensation and ankle reflexes and is scored by assigning points for abnormal findings.A score = 2 was considered abnormal. Abnormality in each item is graded between 0.5 and 1 and at least more than 2 abnormal items are needed to reach the score of neuropathy. ) | 12 months | |
Primary | Change in Electrochemical Skin Conductance | Electrochemical Skin Conductance in hands and feet measured by SUDOSCAN | 12 months | |
Primary | Change in Cardiovascular Autonomic Reflex Tests (CARTs) | CARTs were performed with Autonomic Nervous System Reader and included R-R variation during deep breathing [Mean Circular Resultant , Valsalva maneuver , 30:15 ratio expressed as postural index, and blood pressure response to standing (orthostatic hypotension) | 12 months | |
Primary | Change in Vibration perception threshold | Vibration perception threshold was measured using a Biothesiometer | 12 months | |
Primary | Change in level of pain with painDETECT questionnaire | painDETECT questionnaire consists of seven questions that address the quality of neuropathic pain symptoms; it is completed by the patient and no physical examination is required. The first five questions ask about the gradation of pain, scored from 0 to 5 (never = 0, hardly noticed = 1, slightly = 2; moderately = 3, strongly = 4, very strongly = 5). Question 6 asks about the pain course pattern, scored from -1 to 2, depending on which pain course pattern diagram is selected. The final score between -1 and 38, indicates the likelihood of a neuropathic pain component. A score of = 12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of = 19 suggests that pain is likely to have a neuropathic component (> 90%). A score between these values indicates that the result is uncertain and a more detailed examination is required. | 12 months | |
Primary | Change in quality of life score | Diabetes Quality of Life Brief Clinical Inventory (ThE DQOL questionnaire we used is a 15-items, brief-focused version of the Diabetes Quality of Life (DQOL) questionnaire developed in the DCCT and lowest score means worse quality of life whereas higher values indicate better quality of life) | 12 months | |
Primary | serum vitamin B12 levels | serum vitamin B12 levels | 12 months | |
Secondary | Adverse events | report of any adverse events | 12 months |
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