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NCT03388697 · ClinicalTrials.gov registry record
Validation of a Novel Screening Test for Maternal Insulin Resistance
A clinical trial of Insulin Resistance, Diabetes, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT03388697: Completed study of Insulin Resistance, Diabetes, sponsored by The University of Texas Medical Branch, Galveston.
NCT03388697 is a study of Insulin Resistance, Diabetes that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 100 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03388697, a study of Insulin Resistance, Diabetes, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Development of gestational diabetes (based on the two step approach: 1hr glucose screen \> 135mg/dL and 2/4 abnormal values in a 3 hr OGTT using the Carpenter and Coustan
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 |
What the finished NCT03388697 record still lists
NCT03388697 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT03388697 reports a single indexed study location in Texas.
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.
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).
Who is sponsoring clinical trial NCT03388697?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
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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