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Validation of a Novel Screening Test for Maternal Insulin Resistance

NCT03388697 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Insulin Resistance, Diabetes

Interventions

DIAGNOSTIC_TEST

Quantose IR and Quantose IGT analysis

Testing using Quantose IR and Quantose IGT: The blood draws will be timed to coincide with clinically indicated blood tests as much as possible (e.g. first visit labs, aneuploidy screening, gestational diabetes screening).

DIAGNOSTIC_TEST

HOMA IR the standard testing for insulin resistance

Testing using HOMA IR: Investigators will be measuring fasting insulin and glucose levels (last meal more than 8hrs before testing i.e. overnight fasting) from EDTA-plasma samples. After collection, the samples will be spun and plasma obtained. Samples will be stored until testing. The investigators will be using the following computation to calculate HOMA.

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Antonio Saad, MD · UTMB Galveston

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2019-07-15
Completion
2019-07-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03388697 on ClinicalTrials.gov