Insulin Resistance, Diabetes Clinical Trial
Official title:
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.
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.
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