Effect of cholecalciferol as adjunctive therapy with insulin on protective immunologic profile and decline of residual β-cell function in new-onset type 1 diabetes mellitus
| Autor: | Sergio Atala Dib, Claudia Finazzo, Alberto José da Silva Duarte, Monica Andrade Lima Gabbay, Maria Notomi Sato |
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| Rok vydání: | 2012 |
| Předmět: |
Male
medicine.medical_specialty Adolescent medicine.medical_treatment Placebo Body Mass Index chemistry.chemical_compound Double-Blind Method Diabetes mellitus Internal medicine Prevalence Medicine Humans Hypoglycemic Agents Insulin Cumulative incidence Prospective Studies Age of Onset Child Cholecalciferol Type 1 diabetes B-Lymphocytes Immunity Cellular C-Peptide Dose-Response Relationship Drug business.industry C-peptide Vitamins medicine.disease Hemoglobin A Endocrinology Diabetes Mellitus Type 1 Treatment Outcome chemistry Pediatrics Perinatology and Child Health Cytokines Drug Therapy Combination Female business Brazil |
| Zdroj: | Archives of pediatricsadolescent medicine. 166(7) |
| ISSN: | 1538-3628 |
| Popis: | Objective To evaluate the effect of vitamin D 3 on cytokine levels, regulatory T cells, and residual β-cell function decline when cholecalciferol (vitamin D 3 administered therapeutically) is given as adjunctive therapy with insulin in new-onset type 1 diabetes mellitus (T1DM). Design and Setting An 18-month (March 10, 2006, to October 28, 2010) randomized, double-blind, placebo-controlled trial was conducted at the Diabetes Center of Sao Paulo Federal University, Sao Paulo, Brazil. Participants Thirty-eight patients with new-onset T1DM with fasting serum C-peptide levels greater than or equal to 0.6 ng/mL were randomly assigned to receive daily oral therapy of cholecalciferol, 2000 IU, or placebo. Main Outcome Measure Levels of proinflammatory and anti-inflammatory cytokines, chemokines, regulatory T cells, hemoglobin A 1c , and C-peptide; body mass index; and insulin daily dose. Results Mean (SD) chemokine ligand 2 (monocyte chemoattractant protein 1) levels were significantly higher (184.6 [101.1] vs 121.4 [55.8] pg/mL) at 12 months, as well as the increase in regulatory T-cell percentage (4.55% [1.5%] vs 3.34% [1.8%]) with cholecalciferol vs placebo. The cumulative incidence of progression to undetectable (≤0.1 ng/mL) fasting C-peptide reached 18.7% in the cholecalciferol group and 62.5% in the placebo group; stimulated C-peptide reached 6.2% in the cholecalciferol group and 37.5% in the placebo group at 18 months. Body mass index, hemoglobin A 1c level, and insulin requirements were similar between the 2 groups. Conclusions Cholecalciferol used as adjunctive therapy with insulin is safe and associated with a protective immunologic effect and slow decline of residual β-cell function in patients with new-onset T1DM. Cholecalciferol may be an interesting adjuvant in T1DM prevention trials. |
| Databáze: | OpenAIRE |
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