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• W2185089898 abstract "RESEARCH DESIGN AND METHODS — We screened 103,391 first- and seconddegree relatives of patients with type 1 diabetes and analyzed 97,273 samples for islet cell antibodies. A total of 3,483 were antibody positive; 2,523 underwent genetic, immunological, and metabolic staging to quantify risk of developing diabetes; 388 had a 5-year risk projection of 26 –50%; and 372 (median age 10.25 years) were randomly assigned to oral insulin (7.5 mg/day) or placebo. Oral glucose tolerance tests were performed every 6 months. The median follow-up was 4.3 years, and the primary end point was diagnosis of diabetes. RESULTS — Diabetes was diagnosed in 44 oral insulin and 53 placebo subjects. Annualized rate of diabetes was similar in both groups: 6.4% with oral insulin and 8.2% with placebo (hazard ratio 0.764, P 0.189). In a hypothesis-generating analysis of a subgroup with insulin autoantibody (IAA) levels confirmed (on two occasions) 80 nU/ml (n 263), there was the suggestion of benefit: annualized diabetes rate 6.2% with oral insulin and 10.4% with placebo (0.566, P 0.015). CONCLUSIONS — It is possible to identify individuals at high risk for type 1 diabetes and to enroll them in a large, multisite, randomized, controlled clinical trial. However, oral insulin did not delay or prevent type 1 diabetes. Further studies are needed to explore the potential role of oral insulin in delaying diabetes in relatives similar to those in the subgroup with higher IAA levels. Diabetes Care 28:1068–1076, 2005 T he Diabetes Prevention Trial–Type 1 (DPT-1) was a randomized controlled clinical initiative designed to determine whether it is possible to prevent or delay the onset of overt diabetes in relatives of patients with type 1 diabetes. DPT-1 included two separate trials. Relatives were screened for islet cell antibodies (ICAs), and those who were positive underwent further testing to assess pro" @default.
• W2185089898 created "2016-06-24" @default.
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• W2185089898 date "2005-01-01" @default.
• W2185089898 modified "2023-09-27" @default.
• W2185089898 title "Effects of Oral Insulin in Relatives of Patients With Type 1 Diabetes" @default.
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