Insulin Resistance, DiabetesNCT03388697
Validation of a Novel Screening Test for Maternal Insulin Resistance
An observational study of Insulin Resistance, Diabetes, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Diabetes
- What is being tested?
- Quantose IR and Quantose IGT analysis and HOMA IR the standard testing for insulin resistance
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 15 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Insulin Resistance, Diabetes
- Being tested
- Quantose IR and Quantose IGT analysis, HOMA IR the standard testing for insulin resistance
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantose IR and Quantose IGT analysisDiagnostic test
Also called QUANTOSE® IR, QUANTOSE® IGTT
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).
HOMA IR the standard testing for insulin resistanceDiagnostic test
Also called HOMA IR
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 28 0/7 weeks of gestation
Secondary outcomes (7)
Insulin resistance
Defined as abnormal HOMA IR
Measured: Up to 28 0/7 weeks of gestation
Fasting Plasma glucose
Measuring plasma glucose
Measured: Up to 28 0/7 weeks of gestation
Fasting Insulin
Measuring plasma insulin level
Measured: Up to 28 0/7 weeks of gestation
1 hour glucola
after receiving 50grams glucose load po and plasma glucose level is drawn 1 hour later
Measured: Up to 28 0/7 weeks of gestation
Perinatal death
stillbirths plus early neonatal deaths (under 7 days)
Measured: up to 7 days after delivery
Neonatal hypoglycemia
Neonate plasma glucose < 90mg/dL
Measured: up to 7 days after delivery
NICU admission
Admission to the neonatal intensive care unit
Measured: up to 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start15 Dec 2017
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Insulin Resistance, DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Saad, MD, Principal investigator, UTMB Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388697
- Sponsor's protocol ID
- 17-0228
- Status last verified
- Feb 2019
- First submitted
- 7 Dec 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 4852112Harris MI. Epidemiologic studies on the pathogenesis of non-insulin-dependent diabetes mellitus (NIDDM). Clin Invest Med. 1995 Aug;18(4):231-9.
PubMed 8549007Lyssenko 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.
PubMed 19020324Reaven 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.
PubMed 10212844Eid 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.
PubMed 32894869
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Screening Test for Maternal Insulin Resistance and Predicting Maternal Fetal Outcomes: A Pilot Study.
- ClinicalTrials.gov ID
- NCT03388697
- Acronym / sponsor ID
- 17-0228
- Conditions
- Insulin Resistance, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantose IR and Quantose IGT analysisAlso: QUANTOSE® IR, QUANTOSE® IGTTTesting 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). | Diagnostic test | – |
| HOMA IR the standard testing for insulin resistanceAlso: HOMA IRTesting 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. | Diagnostic test | – |
Primary outcome
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
7 secondary outcomes
Insulin resistance
Time frame: Up to 28 0/7 weeks of gestation
Fasting Plasma glucose
Time frame: Up to 28 0/7 weeks of gestation
Fasting Insulin
Time frame: Up to 28 0/7 weeks of gestation
1 hour glucola
Time frame: Up to 28 0/7 weeks of gestation
Perinatal death
Time frame: up to 7 days after delivery
Neonatal hypoglycemia
Time frame: up to 7 days after delivery
NICU admission
Time frame: up to 7 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Background: PubMed 4852112Ginsberg 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.
- Background: PubMed 8549007Harris MI. Epidemiologic studies on the pathogenesis of non-insulin-dependent diabetes mellitus (NIDDM). Clin Invest Med. 1995 Aug;18(4):231-9.
- Background: PubMed 19020324Lyssenko 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.
- Background: PubMed 10212844Reaven 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.
- Derived from this study: PubMed 32894869Eid 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.
- Individual participant dataSharing planned: No
Related trials for Insulin Resistance, Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Chrono Nutrition and Insulin Resistance in Diabetes
Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Saad, MD principal investigator
UTMB Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance, Diabetes, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational Diabetes (time frame: Up to 28 0/7 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03388697, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.