Validation of a Novel Screening Test for Maternal Insulin Resistance

Completed

Conditions studied: Insulin Resistance, Diabetes

In brief

This will be a validation study of Quantose IR and Quantose IGT to predict insulin resistance and identify patients with prediabetes. This is a pilot study of 100 subjects. Based on the results of this initial trial, investigators plan to perform a larger trial at UTMB. Quantose IR is a fasting blood test for insulin resistance and prediabetes, and is clinically validated in non-pregnant individuals. The Quantose IR Score is based on three novel nonglycemic biomarkers, as well as insulin, and provides a comprehensive measure of insulin resistance. These analytes include: * α-HB (α-hydroxybutyrate): positively correlated with insulin resistance and indicative of early β-cell dysfunction. * L-GPC (linoleoyl-glycerophosphocholine): negatively correlated with insulin resistance and impaired glucose tolerance. * Oleic Acid: positively correlated with increasing lipolysis and insulin resistance. * Insulin: increased insulin is characteristic of insulin resistance and is an independent risk factor for type 2 diabetes and cardiovascular disease. Quantose IGT is designed to estimate the risk of being IGT. It is calculated from a multiple logistic regression model based on the fasting plasma levels of: * Glucose. * α-HB. * β-HB. * 4-methyl-2-oxopentanoic acid. * LGPC. * Oleic acid. * Serine. * Vitamin B5. Participants in the study will be consenting to data collection and two visits for lab draw. The investigators will then evaluate the performance of the Quantose IR and Quantose IGT in the study population.

Key facts

Study ID
NCT03388697
Run by
The University of Texas Medical Branch, Galveston
People needed
100
Starts
2017-12-15
Expected to finish
2019-07-15
Last updated by the study team
2020-04-29

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Where it is running

Full record on ClinicalTrials.gov

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