Validation of a Novel Screening Test for Maternal Insulin Resistance

Validation of a Novel Screening Test for Maternal Insulin Resistance and Predicting Maternal Fetal Outcomes: A Pilot Study.

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.

Study Overview

Detailed Description

This is a prospective cohort non-interventional study. Subjects will be identified during the time of a prenatal visit at one of the UTMB clinics. All necessary institutional and regulatory approval will be obtained prior to enrolling any candidates for this study.

Potential subjects that are not patients of the investigator or patients of the study team members, they will not be contacted by study staff unless they have been informed of the study by their medical provider and express an interest in receiving more information on the study or wish to enroll in the study. Under the direction of the PI, trained research staff will be available in the UTMB prenatal care clinics to screen and consent subjects according to study protocol. The Perinatal Research Division (PRD) has staff based in the UTMB Maternal Health (OB) clinics. These research staff members will screen the charts and electronic medical records of prenatal patients receiving care in the OB clinics. In order to contact potential study participants, the HIPAA waiver is submitted.

In addition, the OB clinic staff will be in serviced on the study and encouraged to refer potential subjects to the PRD staff. Other than the blood samples for this study, the management of pregnancy and delivery will be according to the standard of care at UTMB and will be up to the clinical provider.

Blood samples will be collected during 2 windows, early window (gestational age 10 0/7 to 13 6/7 weeks) and late window (gestational age 24 0/7 to 28 0/7 weeks) and stored at -800C in our perinatal research division. An aliquot will be sent to Metabolon to run the Quantose IR and Quantose IGT. The laboratory and the investigators will be blinded to the outcomes of the patient.

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: The 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.

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.

Study Type


Enrollment (Actual)


Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Galveston, Texas, United States, 77555
        • Ashley Salazar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 49 years (Adult)

Accepts Healthy Volunteers


Genders Eligible for Study


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.


Inclusion Criteria:

  • 18 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

Exclusion Criteria:


Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational Diabetes
Time Frame: Up to 28 0/7 weeks of gestation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance
Time Frame: Up to 28 0/7 weeks of gestation
Defined as abnormal HOMA IR
Up to 28 0/7 weeks of gestation
Fasting Plasma glucose
Time Frame: Up to 28 0/7 weeks of gestation
Measuring plasma glucose
Up to 28 0/7 weeks of gestation
Fasting Insulin
Time Frame: Up to 28 0/7 weeks of gestation
Measuring plasma insulin level
Up to 28 0/7 weeks of gestation
1 hour glucola
Time Frame: Up to 28 0/7 weeks of gestation
after receiving 50grams glucose load po and plasma glucose level is drawn 1 hour later
Up to 28 0/7 weeks of gestation
Perinatal death
Time Frame: up to 7 days after delivery
stillbirths plus early neonatal deaths (under 7 days)
up to 7 days after delivery
Neonatal hypoglycemia
Time Frame: up to 7 days after delivery
Neonate plasma glucose < 90mg/dL
up to 7 days after delivery
NICU admission
Time Frame: up to 7 days after delivery
Admission to the neonatal intensive care unit
up to 7 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


  • Principal Investigator: Antonio Saad, MD, UTMB Galveston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

July 15, 2019

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

April 29, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

February 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?


Drug and device information, study documents

Studies a U.S. FDA-regulated drug product


Studies a U.S. FDA-regulated device product


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Clinical Trials on Insulin Resistance, Diabetes