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Validation of a Novel Screening Test for Maternal Insulin Resistance
NCT03388697 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DIAGNOSTIC_TEST Quantose IR and Quantose IGT analysis
- DIAGNOSTIC_TEST HOMA IR the standard testing for insulin resistance
Study Locations (1)
Texas
- Ashley Salazar — Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2019-07-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03388697
The ClinicalTrials.gov registry entry for NCT03388697 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 132 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Insulin Resistance, Diabetes appearing as the primary indexed condition, and to 2 interventions — of which Quantose IR and Quantose IGT analysis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03388697 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03388697 about?
NCT03388697 is a clinical study titled "Validation of a Novel Screening Test for Maternal Insulin Resistance". 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 blo...
What is the current status of trial NCT03388697?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2017-12-15. Estimated completion is 2019-07-15.
What conditions does trial NCT03388697 study?
This clinical trial studies the following conditions: Insulin Resistance, Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03388697?
The interventions under investigation include: Quantose IR and Quantose IGT analysis (DIAGNOSTIC_TEST), HOMA IR the standard testing for insulin resistance (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03388697?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 132 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03388697 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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