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Haller, Michael J.; Schatz, Desmond A.; Skyler, Jay S.; Krischer, Jeffrey P.; Bundy, Brian N.; Miller, Jessica L.; Atkinson, Mark A.; Becker, Dorothy J.; Baidal, David; DiMeglio, Linda A.; Gitelman, Stephen E.; Goland, Robin; Gottlieb, Peter A.; Herold, Kevan C.; Marks, Jennifer B.; Moran, Antoinette; Rodriguez, Henry; Russell, William; Wilson, Darrell M.; Greenbaum, Carla J.; Greenbaum, C.; Atkinson, M.; Baidal, D.; Battaglia, M.; [...]

Low-Dose Anti-Thymocyte Globulin (ATG) Preserves β-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes

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  • Medientyp: E-Artikel
  • Titel: Low-Dose Anti-Thymocyte Globulin (ATG) Preserves β-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes
  • Beteiligte: Haller, Michael J.; Schatz, Desmond A.; Skyler, Jay S.; Krischer, Jeffrey P.; Bundy, Brian N.; Miller, Jessica L.; Atkinson, Mark A.; Becker, Dorothy J.; Baidal, David; DiMeglio, Linda A.; Gitelman, Stephen E.; Goland, Robin; Gottlieb, Peter A.; Herold, Kevan C.; Marks, Jennifer B.; Moran, Antoinette; Rodriguez, Henry; Russell, William; Wilson, Darrell M.; Greenbaum, Carla J.; Greenbaum, C.; Atkinson, M.; Baidal, D.; Battaglia, M.; [...]
  • Erschienen: American Diabetes Association, 2018
  • Erschienen in: Diabetes Care
  • Sprache: Englisch
  • DOI: 10.2337/dc18-0494
  • ISSN: 0149-5992; 1935-5548
  • Schlagwörter: Advanced and Specialized Nursing ; Endocrinology, Diabetes and Metabolism ; Internal Medicine
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>A pilot study suggested that combination therapy with low-dose anti-thymocyte globulin (ATG) and pegylated granulocyte colony-stimulating factor (GCSF) preserves C-peptide in established type 1 diabetes (T1D) (duration 4 months to 2 years). We hypothesized that 1) low-dose ATG/GCSF or 2) low-dose ATG alone would slow the decline of β-cell function in patients with new-onset T1D (duration &amp;lt;100 days).</jats:p> </jats:sec> <jats:sec> <jats:title>RESEARCH DESIGN AND METHODS</jats:title> <jats:p>A three-arm, randomized, double-masked, placebo-controlled trial was performed by the Type 1 Diabetes TrialNet Study Group in 89 subjects: 29 subjects randomized to ATG (2.5 mg/kg intravenously) followed by pegylated GCSF (6 mg subcutaneously every 2 weeks for 6 doses), 29 to ATG alone (2.5 mg/kg), and 31 to placebo. The primary end point was mean area under the curve (AUC) C-peptide during a 2-h mixed-meal tolerance test 1 year after initiation of therapy. Significance was defined as one-sided P value &amp;lt; 0.025.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>The 1-year mean AUC C-peptide was significantly higher in subjects treated with ATG (0.646 nmol/L) versus placebo (0.406 nmol/L) (P = 0.0003) but not in those treated with ATG/GCSF (0.528 nmol/L) versus placebo (P = 0.031). HbA1c was significantly reduced at 1 year in subjects treated with ATG and ATG/GCSF, P = 0.002 and 0.011, respectively.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>Low-dose ATG slowed decline of C-peptide and reduced HbA1c in new-onset T1D. Addition of GCSF did not enhance C-peptide preservation afforded by low-dose ATG. Future studies should be considered to determine whether low-dose ATG alone or in combination with other agents may prevent or delay the onset of the disease.</jats:p> </jats:sec>
  • Zugangsstatus: Freier Zugang