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
Gabbay MA, Sato MN, Finazzo C, Duarte AJ, Dib SA
Archives of pediatrics & adolescent medicine · 106 citas
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Publicación
- Publicado
- 2012-07-01 · Arch Pediatr Adolesc Med · vol. 166 · número 7 · págs. 601–7
- Editorial
- American Medical Association
- Citado
- 149 citas · más que el 96% de estudios similares · 5.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 54 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Diabetes and associated disorders · Vitamin D Research Studies · Diabetes Management and Research
- Palabras clave
- vitamin D3, type 1 diabetes, new-onset diabetes, residual beta-cell function, regulatory T cells, cytokines, chemokine ligand 2, MCP-1, diabetes prevention
- MeSH
- b-lymphocytes, humans, diabetes mellitus, type 1, cholecalciferol, insulin, c-peptide, vitamins, cytokines, hypoglycemic agents, body mass index, treatment outcome, drug therapy, combination, prevalence, prospective studies, double-blind method, age of onset, immunity, cellular, dose-response relationship, drug, adolescent, child, brazil, female, male
5 autores
- Mônica Andrade Lima Gabbay🇧🇷 · autor de correspondenciaUniversidade Federal de São Paulo
- Maria Notomi Sato🇧🇷Universidade Federal de São Paulo
- Claudia Finazzo🇧🇷Universidade de São Paulo; Universidade Federal de São Paulo
- Alberto J. S. Duarte🇧🇷Universidade Federal de São Paulo
- Sérgio Atala Dib🇧🇷Universidade Federal de São Paulo
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
To evaluate the effect of vitamin D3 on cytokine levels, regulatory T cells, and residual β-cell function decline when cholecalciferol (vitamin D3 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 São Paulo Federal University, São 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 A1c, 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 A1c 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.
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