Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial--Type 1.

摘要: OBJECTIVE This randomized, double-masked, placebo-controlled clinical trial tested whether oral insulin administration could delay or prevent type 1 diabetes in nondiabetic relatives at risk for diabetes. RESEARCH DESIGN AND METHODS We screened 103,391 first- and second-degree of patients with analyzed 97,273 samples islet cell antibodies. A total 3,483 were antibody positive; 2,523 underwent genetic, immunological, metabolic staging to quantify developing diabetes; 388 had a 5-year projection 26-50%; 372 (median age 10.25 years) randomly assigned (7.5 mg/day) placebo. Oral glucose tolerance tests performed every 6 months. The median follow-up was 4.3 years, the primary end point diagnosis RESULTS Diabetes diagnosed 44 53 placebo subjects. Annualized rate similar both groups: 6.4% 8.2% (hazard ratio 0.764, P = 0.189). In hypothesis-generating analysis subgroup autoantibody (IAA) levels confirmed (on two occasions) > =80 nU/ml (n 263), there suggestion benefit: annualized 6.2% 10.4% (0.566, 0.015). CONCLUSIONS It is possible identify individuals high enroll them large, multisite, controlled trial. However, did not Further studies are needed explore potential role delaying those higher IAA levels.