Summary of Study ST001690

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, where it has been assigned Project ID PR001086. The data can be accessed directly via it's Project DOI: 10.21228/M8B123 This work is supported by NIH grant, U2C- DK119886.

See: https://www.metabolomicsworkbench.org/about/howtocite.php

This study contains a large results data set and is not available in the mwTab file. It is only available for download via FTP as data file(s) here.

Study ID	ST001690
Study Title	Untargeted metabolomic analysis of human blood samples via qualitative GC-MS for T1D biomarker identification
Study Type	Qualitative GC-MS biomarker identification
Study Summary	Blood from human subjects at high risk for T1D (and healthy controls; n=4 each) were subjected to parallel unlabeled proteomics, metabolomics, lipidomics, and transcriptomics. The integrated dataset was analyzed using Ingenuity Pathway Analysis (IPA) software for disturbances in the at-risk subjects compared to the controls. The final quadra-omics dataset contained 2292 proteins, 328 miRNAs, 75 metabolites, and 41 lipids that were detected in all samples. Disease/function enrichment analyses consistently indicated increased activation, proliferation, and migration of immune cells, particularly, CD4 T-lymphocytes and macrophages. Integrated molecular network predictions highlighted central involvement and activation of NF-κB, TGF-β, VEGF, arachidonic acid, and arginase, and inhibition of miRNA Let-7a-5p. Parallel multi-omics provided a comprehensive picture of disturbances in high-risk T1D subjects and helped identify an associated integrated biomarker signature, which could ultimately facilitate the classification of T1D progressors from non-progressors.
Institute	Duke University
Department	Duke Molecular Physiology Institute, School of Medicine
Laboratory	Metabolomics
Last Name	Bain
First Name	James
Address	300 N Duke St, Durham, NC, 27701, USA
Email	james.bain@duke.edu
Phone	919 479 2320
Submit Date	2021-02-09
Total Subjects	9
Raw Data Available	Yes
Raw Data File Type(s)	d
Analysis Type Detail	GC-MS
Release Date	2021-06-10
Release Version	1

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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).