title: Effect of standard nicotinamide in the prevention of type 1 diabetes in first degree relatives of persons with type 1 diabetes.
abstract: BACKGROUND
  Nicotinamide has been used with success to prevent type 1 diabetes in animal models and humans. This vitamin B3 derivative has attracting effects on beta-cell protection and regeneration.
  
  
  OBJECTIVE
  To evaluate the effect of standard nicotinamide administration on type 1 diabetes prevention in first degree relatives of persons with type 1 diabetes as well as on the concentrations of islet-cell-related autoantibodies, insulin secretion and peripheral sensitivity.
  
  
  METHODS
  A randomized double-blind placebo controlled intervention trial was conducted in 40 first degree relatives of type 1 diabetic patients. Persistence of ICA ( >or= 10 JDF units) was among inclusion criteria. Participants were randomly allocated oral standard nicotinamide (1.2 g/m2) or placebo for 5 years. Groups were also stratified by age. Islet associated antibodies, fasting blood glucose, fasting plasma insulin concentrations, OGTT, IVGTT and HLA-DR genotyping were performed in all participants. The main criterion to stop treatment was type 1 diabetes development as defined by WHO.
  
  
  RESULTS
  Type 1 diabetes development frequencies were similar between the treatment groups. ICA frequencies at the end of the study, first phase insulin release, and insulin sensitivity did not differ between groups as well. None of the participants suffered from any adverse events described for nicotinamide.
  
  
  CONCLUSIONS
  Type 1 diabetes prevention trial using standard nicotinamide is feasible but fails to prevent or delay the disease onset at the dose we used.
authors.affiliation: Department of Immunology of Diabetes Mellitus, National Institute of Endocrinology, Zapata and D, Vedado, Havana, Cuba. diabetes@infomed.sld.cu
authors.forename: Eduardo
authors.initials: E
authors.lastname: Cabrera-Rode
authors.forename: Gisela
authors.initials: G
authors.lastname: Molina
authors.forename: Celeste
authors.initials: C
authors.lastname: Arranz
authors.forename: Manuel
authors.initials: M
authors.lastname: Vera
authors.forename: Pedro
authors.initials: P
authors.lastname: González
authors.forename: Rolando
authors.initials: R
authors.lastname: Suárez
authors.forename: Mirta
authors.initials: M
authors.lastname: Prieto
authors.forename: Saúl
authors.initials: S
authors.lastname: Padrón
authors.forename: Rafael
authors.initials: R
authors.lastname: León
authors.forename: Juana
authors.initials: J
authors.lastname: Tillan
authors.forename: Igrid
authors.initials: I
authors.lastname: García
authors.forename: Claudio
authors.initials: C
authors.lastname: Tiberti
authors.forename: Olga María
authors.initials: OM
authors.lastname: Rodríguez
authors.forename: Antonio
authors.initials: A
authors.lastname: Gutiérrez
authors.forename: Tamara
authors.initials: T
authors.lastname: Fernández
authors.forename: Amparo
authors.initials: A
authors.lastname: Govea
authors.forename: José
authors.initials: J
authors.lastname: Hernández
authors.forename: Dania
authors.initials: D
authors.lastname: Chiong
authors.forename: Emma
authors.initials: E
authors.lastname: Domínguez
authors.forename: Umberto
authors.initials: U
authors.lastname: Di Mario
authors.forename: Oscar
authors.initials: O
authors.lastname: Díaz-Díaz
authors.forename: Oscar
authors.initials: O
authors.lastname: Díaz-Horta
mesh_terms: D000293:Adolescent; D000328:Adult; D001323:Autoantibodies / Q000097:blood / Q000276:immunology; D001786:Blood Glucose / Q000378:metabolism; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000235:genetics / Q000276:immunology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D020022:Genetic Predisposition to Disease; D005951:Glucose Tolerance Test; D006684:HLA-DR Antigens / Q000097:blood; D006801:Humans; D007328:Insulin / Q000097:blood / Q000378:metabolism; D000078790:Insulin Secretion; D008297:Male; D009536:Niacinamide / Q000031:analogs & derivatives / Q000627:therapeutic use* / Q000652:urine; D011236:Prediabetic State / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D014803:Vitamin B Complex / Q000627:therapeutic use*
chemical_list: D001323:Autoantibodies; D001786:Blood Glucose; D006684:HLA-DR Antigens; D007328:Insulin; C024211:islet cell antibody; D014803:Vitamin B Complex; D009536:Niacinamide; C008472:N-methylnicotinamide