NCT03388697|Completed
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Sponsor study identifier
observational
100
1 country
1
Study Start
December 15, 2017
Actual (reported)Primary Completion
July 15, 2019
Actual (reported)Study Completion
July 15, 2019
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 7, 2017
Actual (reported)December 15, 2017
Actual (reported)January 3, 2018
Actual (reported)July 15, 2019
Actual (reported)July 15, 2019
Actual (reported)Gestational Diabetes
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
Up to 28 0/7 weeks of gestation
Insulin resistance
Up to 28 0/7 weeks of gestation
Fasting Plasma glucose
Up to 28 0/7 weeks of gestation
Fasting Insulin
Up to 28 0/7 weeks of gestation
1 hour glucola
Up to 28 0/7 weeks of gestation
Perinatal death
up to 7 days after delivery
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).
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.
* Known or suspected fetal anomaly. * Pre-gestational diabetes. * Pre-pregnancy hypertension. * Receiving medication that would interfere with Quantose IR or would increase IR (e.g. steroids). * Prisoners.
Ashley Salazar
Galveston, Texas, 77555, United States
Ginsberg H, Olefsky JM, Reaven GM. Further evidence that insulin resistance exists in patients with chemical diabetes. Diabetes. 1974 Aug;23(8):674-8. doi: 10.2337/diab.23.8.674. No abstract available.
Harris MI. Epidemiologic studies on the pathogenesis of non-insulin-dependent diabetes mellitus (NIDDM). Clin Invest Med. 1995 Aug;18(4):231-9.
Lyssenko V, Jonsson A, Almgren P, Pulizzi N, Isomaa B, Tuomi T, Berglund G, Altshuler D, Nilsson P, Groop L. Clinical risk factors, DNA variants, and the development of type 2 diabetes. N Engl J Med. 2008 Nov 20;359(21):2220-32. doi: 10.1056/NEJMoa0801869.
Two tubes (total = 20cc) of blood will be collected from participants who will be asked to fast for minimum of 8 hours prior to blood draw. The samples from both time points will be sent together to Metabolon for Quantose IR and Quantose IGT analysis.
Antonio Saad, MD
UTMB Galveston
100 participants (actual enrollment reported by the registry).
First Submitted
December 7, 2017
First Posted
January 3, 2018
Study Start
December 15, 2017
Actual (reported)Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Reaven GM. Insulin resistance and human disease: a short history. J Basic Clin Physiol Pharmacol. 1998;9(2-4):387-406. doi: 10.1515/jbcpp.1998.9.2-4.387.
Eid J, Kechichian T, Benavides E, Thibodeaux L, Salazar AE, Saade GR, Saad AF. The Quantose Insulin Resistance Test for Maternal Insulin Resistance: A Pilot Study. Am J Perinatol. 2022 Apr;39(5):513-518. doi: 10.1055/s-0040-1716730. Epub 2020 Sep 7.
Primary Completion
July 15, 2019
Actual (reported)Study Completion
July 15, 2019
Actual (reported)Last Updated
April 29, 2020
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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