Fetal MacrosomiaNCT06067685
Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes
An observational study of Fetal Macrosomia and Obesity Complicating Childbirth, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fetal Macrosomia, Obesity Complicating Childbirth, Gestational Diabetes
- What is being tested?
- Observation
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 1 Sep 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients receiving prenatal care and planning to delivery at the University of Kansas Health System. Population includes significant numbers of Black and Hispanic patients. Population also includes significant numbers of self-pay and government-insured patients.
Who may be able to join
- singleton pregnancy
- diagnosis of GDM between 24-32 weeks
- BMI >= 30
Who cannot join
- Conditions known to impact fetal growth.These conditions can develop after study enrollment but cannot be present at enrollment.
- autoimmune conditions treated with medication
- chronic hypertension requiring medication
- preeclampsia
- fetal growth restriction diagnosis
- smoking
Show all 9Show fewer
- illicit drug use
- major fetal anomalies
- fetal genetic conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
This is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. Mothers are asked to provide 2 blood samples, undergo fingerstick blood measurements, and to have their newborns measured for body fat composition in the first 6 months of life.
Read the detailed description
Gestational diabetes (GDM) is a condition of impaired insulin resistance which causes increased morbidity for mothers and newborns due to fetal overgrowth. Traditionally, GDM is diagnosed with a glucose tolerance test, and treatment subsequently focuses singularly on glucose management. However, both glucose and triglycerides (TAG) are fuels for fetal overgrowth. The central hypothesis is that the most effective understanding of fetal overgrowth needs to include both carbohydrates and triglycerides. The study will focus recruitment on patients who have GDM and BMI > 35. The specific aims are 1) Determine the relationship between TAG levels during pregnancy and offspring size, 2) Explore the relationship between TAG levels during pregnancy and adipose tissue accrual (birth weight, body composition and adipose tissue distribution) from birth to six months old, and 3)Examine the relationship between maternal TAG levels and cord c-peptide levels. Mothers are asked to check their serum triglycerides at the time of diagnosis of GDM and at the end of pregnancy. Fingerstick blood measurements of triglycerides are also measured every 2 weeks at prenatal visits. At delivery, cord blood is collected. Infants are examined at 0.5, 3, and 6 months after birth.
- Being tested
- Observation
- Keywords
- fetal macrosomia, large for gestational age infant, gestational diabetes, maternal obesity, triglycerides, fatty acids, fetal overgrowth
- Medical subject headings
- Fetal Macrosomia, Diabetes, Gestational, Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Prospective Observation only. Will record serum triglyceride, fingerstick blood triglyceride measurements, cord c-peptide, and neonatal body fat composition measurements in the first 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Pregnancies with GDM and BMI > 30 | Pregnancies with GDM diagnosed between 24-32 weeks and BMI > 30. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between triglyceride levels and birthweight
Correlation coefficient
Measured: Newborn Day of Life 0
Secondary outcomes (3)
Correlation coefficient between triglyceride levels and total fat mass
Body fat measured by air plethysmography (PeaPod)
Measured: 0.5, 3, and 6 months
Correlation coefficient between triglyceride levels and body fat distribution
central vs peripheral body fat measured from DEXA scan
Measured: 0.5, 3, and 6 months
Correlation coefficient between triglyceride levels and cord c-peptide levels
Correlation coefficient
Measured: Newborn Day of Life 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start10 Aug 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Why it stopped: Unable to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal MacrosomiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gene Lee, MD, University of Kansas Medical Center
- Investigators
- Gene T Lee, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067685
- Sponsor's protocol ID
- 150494
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06067685
- Acronym / sponsor ID
- 150494
- Keywords
- fetal macrosomia, large for gestational age infant, gestational diabetes, maternal obesity, triglycerides, fatty acids, fetal overgrowth
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit subjects
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 5 Oct 2023 (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 is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. Mothers are asked to provide 2 blood samples, undergo fingerstick blood measurements, and to have their newborns measured for body fat composition in the first 6 months of life.
Detailed description
Gestational diabetes (GDM) is a condition of impaired insulin resistance which causes increased morbidity for mothers and newborns due to fetal overgrowth. Traditionally, GDM is diagnosed with a glucose tolerance test, and treatment subsequently focuses singularly on glucose management. However, both glucose and triglycerides (TAG) are fuels for fetal overgrowth. The central hypothesis is that the most effective understanding of fetal overgrowth needs to include both carbohydrates and triglycerides. The study will focus recruitment on patients who have GDM and BMI > 35. The specific aims are 1) Determine the relationship between TAG levels during pregnancy and offspring size, 2) Explore the relationship between TAG levels during pregnancy and adipose tissue accrual (birth weight, body composition and adipose tissue distribution) from birth to six months old, and 3)Examine the relationship between maternal TAG levels and cord c-peptide levels. Mothers are asked to check their serum triglycerides at the time of diagnosis of GDM and at the end of pregnancy. Fingerstick blood measurements of triglycerides are also measured every 2 weeks at prenatal visits. At delivery, cord blood is collected. Infants are examined at 0.5, 3, and 6 months after birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancies with GDM and BMI > 30 | – | Other: ObservationPregnancies with GDM diagnosed between 24-32 weeks and BMI > 30. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving prenatal care and planning to delivery at the University of Kansas Health System. Population includes significant numbers of Black and Hispanic patients. Population also includes significant numbers of self-pay and government-insured patients.
Key inclusion criteria (3 listed)
- singleton pregnancy
- diagnosis of GDM between 24-32 weeks
- BMI >= 30
Key exclusion criteria (9 listed)
- Conditions known to impact fetal growth.These conditions can develop after study enrollment but cannot be present at enrollment.
- autoimmune conditions treated with medication
- chronic hypertension requiring medication
- preeclampsia
- fetal growth restriction diagnosis
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 |
|---|---|---|
| ObservationProspective Observation only. Will record serum triglyceride, fingerstick blood triglyceride measurements, cord c-peptide, and neonatal body fat composition measurements in the first 6 months. | Other | Pregnancies with GDM and BMI > 30 |
Primary outcome
Correlation coefficient between triglyceride levels and birthweight
Time frame: Newborn Day of Life 0
Correlation coefficient
3 secondary outcomes
Correlation coefficient between triglyceride levels and total fat mass
Time frame: 0.5, 3, and 6 months
Correlation coefficient between triglyceride levels and body fat distribution
Time frame: 0.5, 3, and 6 months
Correlation coefficient between triglyceride levels and cord c-peptide levels
Time frame: Newborn Day of Life 0
Results and safety
The study was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Gene T Lee, MD principal investigator
University of Kansas Medical Center
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 Fetal Macrosomia and Obesity Complicating Childbirth, run by University of Kansas Medical Center 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 Sep 2024. 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 was stopped early (reason given: Unable to recruit subjects). Results are not available in the source record.
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?
Correlation coefficient between triglyceride levels and birthweight (time frame: Newborn Day of Life 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.