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Validation of a Novel Screening Test for Maternal Insulin Resistance

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ClinicalTrials.gov Identifier: NCT03388697
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Tracking Information
First Submitted Date December 7, 2017
First Posted Date January 3, 2018
Last Update Posted Date May 29, 2019
Actual Study Start Date December 15, 2017
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2017)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03388697 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 22, 2017)
  • Insulin resistance [ Time Frame: Up to 28 0/7 weeks of gestation ]
    Defined as abnormal HOMA IR
  • Fasting Plasma glucose [ Time Frame: Up to 28 0/7 weeks of gestation ]
    Measuring plasma glucose
  • Fasting Insulin [ Time Frame: Up to 28 0/7 weeks of gestation ]
    Measuring plasma insulin level
  • 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
  • Perinatal death [ Time Frame: up to 7 days after delivery ]
    stillbirths plus early neonatal deaths (under 7 days)
  • Neonatal hypoglycemia [ Time Frame: up to 7 days after delivery ]
    Neonate plasma glucose < 90mg/dL
  • NICU admission [ Time Frame: up to 7 days after delivery ]
    Admission to the neonatal intensive care unit
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Validation of a Novel Screening Test for Maternal Insulin Resistance
Official Title Validation of a Novel Screening Test for Maternal Insulin Resistance and Predicting Maternal Fetal Outcomes: A Pilot Study.
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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

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.

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.
Condition Insulin Resistance, Diabetes
Intervention
  • Diagnostic Test: Quantose IR and Quantose IGT analysis
    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).
    Other Name: QUANTOSE® IR, QUANTOSE® IGTT
  • Diagnostic Test: HOMA IR the standard testing for insulin resistance
    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.
    Other Name: HOMA IR
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 22, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 15, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

-

Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant women
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Antonio Saad, MD 409 7772 0982 afsaad@utmb.edu
Contact: Ashley Salazar 409 772 0312 assalaza@utmb.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03388697
Other Study ID Numbers 17-0228
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party The University of Texas Medical Branch, Galveston
Study Sponsor The University of Texas Medical Branch, Galveston
Collaborators Not Provided
Investigators
Principal Investigator: Antonio Saad, MD UTMB Galveston
PRS Account The University of Texas Medical Branch, Galveston
Verification Date February 2019