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Office for Human Research Protections (OHRP)

Precursors to Diabetes in Japanese American Youth

Some information in the following documents is exempt from disclosure under Federal statutes and has been redacted.


Requesting IRB:

University of Washington and Children's Hospital and Regional Medical Center

Study Summary:

This study aims to better understand the metabolic changes in children that precede the development of type 2 diabetes, and the influence of Asian ethnicity on diabetes risk, by describing 1) metabolic changes and adipose factors associated. with the insulin resistance metabolic syndrome in prepubertal children; 2) the relationship between pancreatic islet B-cell function and family history of type 2 diabetes; 3) changes in these factors as children progress through puberty; 4) the relationship of diet and physical activity to the metabolic and adipose factors; and 5) the relationship between Japanese ancestry and metabolic, adipose, and insulin secretion factors. It proposes a longitudinal cohort study of 450 prepubertal (8-10 year old) nondiabetic Japanese-American and Caucasian children. Measurements at baseline and 2 year follow-up would include: lipids and LDL particle size, insulin, C-peptide, proinsulin, glucose tolerance and insulin secretion determined by an intravenous glucose tolerance test, plasminogen activator inhibitor-1, fibrinogen, Creactive protein, insulin- like growth factor-1 and insulin-like growth factor binding protein-3, body composition by DEXA, and intra-abdominal fat by MRI.

Funding Source:

National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health

OHRP Correspondence

Report on expert panel review

NIH grant application, excerpts

Informed consent (adult) and assent (child/minor)

IRB Protocol Application

Federal Register notice requesting public comments




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