Metabolomics Workbench : NIH Data Repository

MB Sample ID: SA156649

Local Sample ID:	1
Subject ID:	SU001767
Subject Type:	Human
Subject Species:	Homo sapiens
Taxonomy ID:	9606

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Treatment:

Treatment ID:	TR001780
Treatment Summary:	Subjects in the TN-01 study are tested semi-annually for the appearance of new or additional autoantibodies and are evaluated metabolically by oral glucose tolerance test (OGTT) to assess their progression toward clinical diagnosis of T1D. Samples from healthy subjects (n=4) were collected as part of another study approved by the IRB of the University of Miami (study number 11995-115). These trials are conducted in accordance with the principles of the Declaration of Helsinki and consistent with the Good Clinical Practice guidelines of the International Conference on Harmonization. The protocol for the ancillary study, under which the current multi-omics analyses were performed, was approved by TrialNet (study ID number 195) and its IRB. The four high-risk subjects in the present report were staged for their risk level according to the TrialNet staging/scoring system, which considers family history, genetic susceptibility according to haplotype (e.g., HLA-DQ/DR), the number of autoantibodies, and OGTT results as follows: low-risk (1 autoantibody and normal OGTT); moderate-risk (2–3 autoantibodies and normal OGTT); high-risk (4–5 autoantibodies and normal OGTT); and very high-risk (4–5 autoantibodies and abnormal OGTT).

Treatment ID:

TR001780

Treatment Summary:

Subjects in the TN-01 study are tested semi-annually for the appearance of new or additional autoantibodies and are evaluated metabolically by oral glucose tolerance test (OGTT) to assess their progression toward clinical diagnosis of T1D. Samples from healthy subjects (n=4) were collected as part of another study approved by the IRB of the University of Miami (study number 11995-115). These trials are conducted in accordance with the principles of the Declaration of Helsinki and consistent with the Good Clinical Practice guidelines of the International Conference on Harmonization. The protocol for the ancillary study, under which the current multi-omics analyses were performed, was approved by TrialNet (study ID number 195) and its IRB. The four high-risk subjects in the present report were staged for their risk level according to the TrialNet staging/scoring system, which considers family history, genetic susceptibility according to haplotype (e.g., HLA-DQ/DR), the number of autoantibodies, and OGTT results as follows: low-risk (1 autoantibody and normal OGTT); moderate-risk (2–3 autoantibodies and normal OGTT); high-risk (4–5 autoantibodies and normal OGTT); and very high-risk (4–5 autoantibodies and abnormal OGTT).