Validation of a Novel Screening Test for Maternal Insulin Resistance

NCT03388697 | Completed

• 1 other identifier: 17-0228
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Interventions

Quantose IR and Quantose IGT analysis DIAGNOSTIC_TEST

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).

Also known as: QUANTOSE® IR, QUANTOSE® IGTT

HOMA IR the standard testing for insulin resistance DIAGNOSTIC_TEST

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.

Also known as: HOMA IR

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* 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.

You may qualify if:

• years or older.
• Singleton pregnancy.
• Able to provide consent.
• Gestational age 10 0/7 to 13 6/7 weeks.
• Planned delivery at UTMB (John Sealy Hospital (JSH) or League City Hospital Campus.
• Pre-pregnancy or early pregnancy BMI \> or = 30 kg/m2

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Ashley Salazar

Galveston, Texas, 77555, United States

Location

Related Publications (5)

• 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.

  PMID: 4852112 BACKGROUND

• Harris MI. Epidemiologic studies on the pathogenesis of non-insulin-dependent diabetes mellitus (NIDDM). Clin Invest Med. 1995 Aug;18(4):231-9.

  PMID: 8549007 BACKGROUND

• 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.

  PMID: 19020324 BACKGROUND

• 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.

  PMID: 10212844 BACKGROUND

• 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.

  PMID: 32894869 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Antonio Saad, MD

  UTMB Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: January 3, 2018
• Study Start: December 15, 2017
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: April 29, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)