Fetal MacrosomiaNCT00826904
Regulation Of Maternal Fuel Supply And Neonatal Adiposity
An observational study of Fetal Macrosomia and Gestational Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine whether unrecognized maternal hyperglycemia and postprandial lipemia early or late in gestation predicts excess neonatal adiposity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Macrosomia, Gestational Diabetes
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to 20 Mar 2017
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Lean (BMI 20-26 kg/m2)and Obese (BMI 30-38 kg/m2) pregnant women (age 18-35 yr) without chronic medical conditions or obstetric complications will be enrolled at 12-14 weeks gestation.
Who may be able to join
- Age 18 - 35 yr
- Pregnant (12-14 weeks gestation)
- Lean (BMI 20-26 kg/m2)
- Obese (BMI 30-38 kg/m2)
Who cannot join
- Age < 18 or > 35 yr
- Pre-existing diabetes
- Chronic medical conditions:
- hypertension,
- hepatitis,
- Human immunodeficiency Virus (HIV),
Show all 26Show fewer
- Thrombophilias,
- History of:
- thromboembolism,
- renal disease,
- neurologic diseases,
- rheumatologic disorders,
- gastrointestinal disease,
- cardiac dysfunction, or
- pulmonary disease
- Obstetric conditions:
- history of stillbirth,
- severe growth restriction,
- severe preeclampsia, or
- placental abruption
- Medications known to affect lipid or glucose metabolism:
- Metformin,
- glucocorticoids,
- beta agonists or blockers, or
- antihypertensives
- Use of recreational drugs, alcohol or tobacco.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
The purpose of this study is to determine whether unrecognized maternal hyperglycemia and postprandial lipemia early or late in gestation predicts excess neonatal adiposity.
Read the detailed description
Mounting epidemiologic evidence suggests that maternal obesity and Gestational Diabetes Mellitus (GDM) independently influence size at birth and disease susceptibility later in life. A major gap in the understanding of fetal programming is the knowledge of whether and how exposure to excess maternal fuels in the absence of frank hyperglycemia impacts fetal fat accretion. The investigators hypothesis is that neonatal adiposity results from unrecognized maternal hyperglycemia and excess lipid availability in gestation, in part caused by excessive lipolysis in the white adipose tissue of obese women, some of whom will be subsequently diagnosed as having GDM. In Aim 1 the investigators will test the hypothesis that in obese women, some of whom will later be diagnosed with GDM, increased lipolysis and unrecognized hyperglycemia and hypertriglyceridemia occur earlier in gestation than in lean women, resulting in increased plasma non-esterified fatty acids (NEFA), glycerol, triglycerides (TGs), and glucose available for fetal metabolism. In Aim 2 the investigators will test the hypothesis that fetal adiposity by ultrasound and neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA) are strongly correlated with excess lipid and glucose availability in obese mothers early in gestation, regardless of GDM status, and that fasting biomarkers of neonatal insulin sensitivity will correlate with neonatal adiposity. In Aim 3 the investigators will test the hypothesis that the in-vitro suppression of lipolysis in white adipose tissue correlates with excess NEFA and TG availability in-vivo and is predictive of neonatal adiposity. The elucidation of specific derangements in both glucose and lipid metabolism and their timing in gestation in mothers who deliver infants with excess adiposity could challenge our current screening methods and entirely redirect our treatment to target the responsible maternal fuels. On a public health level, this research is instrumental to the investigators understanding of how an intrauterine environment may deliver excess glucose and/or lipids to the fetus and contribute to the genesis of the pediatric obesity epidemic. Such information may result in new treatment strategies in pregnant women to normalize fetal growth.
- Conditions
- Fetal Macrosomia, Gestational Diabetes
- Keywords
- Fetal programming, Fetal macrosomia, Fetal health, Gestational diabetes, Maternal health, Maternal obesity
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Lean | Healthy, pregnant women with BMI of 20 - 26 kg/m2 | |
| Obese | Healthy, obese pregnant women with BMI 30 - 38 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neonatal adiposity by maternal Triglycerides, Glucose
Prediction of neonatal adiposity by maternal Triglycerides and Glucose
Measured: 14-16, 26-28 weeks gestation
Change in maternal postprandial lipemia
Measured: 26-28 weeks gestation
Secondary outcomes (5)
Change in maternal postprandial lipemia
Measured: 14-16, 26-28 weeks gestation
Change in maternal postprandial glycemia
Measured: 14-16, 26-28 weeks gestation
Prediction of neonatal adiposity by placental and maternal adipose tissue lipoprotein lipase (LPL) activity
adipose tissue biopsy/Neonatal adiposity by Dual x-ray Absorptiometry (DXA)
Measured: 26-28 weeks gestation
Correlation of neonatal adiposity and fetal growth
Neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA)
Measured: 28-30 weeks gestation
Correlation of neonatal adiposity and fetal growth
Neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA)
Measured: 36-37 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startOct 2007
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fetal MacrosomiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda A Barbour, MD, MSPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826904
- Sponsor's protocol ID
- 07-0535
- Other IDs
- R56DK078645
- Status last verified
- Oct 2019
- First submitted
- 21 Jan 2009
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.
PubMed 29931812
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation Of Maternal Fuel Supply And Neonatal Adiposity
- ClinicalTrials.gov ID
- NCT00826904
- Acronym / sponsor ID
- 07-0535
- Conditions
- Fetal Macrosomia, Gestational Diabetes
- Keywords
- Fetal programming, Fetal macrosomia, Fetal health, Gestational diabetes, Maternal health, Maternal obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2007
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 22 Jan 2009 (estimated)
- 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.
The purpose of this study is to determine whether unrecognized maternal hyperglycemia and postprandial lipemia early or late in gestation predicts excess neonatal adiposity.
Detailed description
Mounting epidemiologic evidence suggests that maternal obesity and Gestational Diabetes Mellitus (GDM) independently influence size at birth and disease susceptibility later in life. A major gap in the understanding of fetal programming is the knowledge of whether and how exposure to excess maternal fuels in the absence of frank hyperglycemia impacts fetal fat accretion. The investigators hypothesis is that neonatal adiposity results from unrecognized maternal hyperglycemia and excess lipid availability in gestation, in part caused by excessive lipolysis in the white adipose tissue of obese women, some of whom will be subsequently diagnosed as having GDM. In Aim 1 the investigators will test the hypothesis that in obese women, some of whom will later be diagnosed with GDM, increased lipolysis and unrecognized hyperglycemia and hypertriglyceridemia occur earlier in gestation than in lean women, resulting in increased plasma non-esterified fatty acids (NEFA), glycerol, triglycerides (TGs), and glucose available for fetal metabolism. In Aim 2 the investigators will test the hypothesis that fetal adiposity by ultrasound and neonatal adiposity by Dual-energy X-ray Absorptiometry (DXA) are strongly correlated with excess lipid and glucose availability in obese mothers early in gestation, regardless of GDM status, and that fasting biomarkers of neonatal insulin sensitivity will correlate with neonatal adiposity. In Aim 3 the investigators will test the hypothesis that the in-vitro suppression of lipolysis in white adipose tissue correlates with excess NEFA and TG availability in-vivo and is predictive of neonatal adiposity. The elucidation of specific derangements in both glucose and lipid metabolism and their timing in gestation in mothers who deliver infants with excess adiposity could challenge our current screening methods and entirely redirect our treatment to target the responsible maternal fuels. On a public health level, this research is instrumental to the investigators understanding of how an intrauterine environment may deliver excess glucose and/or lipids to the fetus and contribute to the genesis of the pediatric obesity epidemic. Such information may result in new treatment strategies in pregnant women to normalize fetal growth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean | – | –Healthy, pregnant women with BMI of 20 - 26 kg/m2 |
| Obese | – | –Healthy, obese pregnant women with BMI 30 - 38 kg/m2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Lean (BMI 20-26 kg/m2)and Obese (BMI 30-38 kg/m2) pregnant women (age 18-35 yr) without chronic medical conditions or obstetric complications will be enrolled at 12-14 weeks gestation.
Key inclusion criteria (4 listed)
- Age 18 - 35 yr
- Pregnant (12-14 weeks gestation)
- Lean (BMI 20-26 kg/m2)
- Obese (BMI 30-38 kg/m2)
Key exclusion criteria (26 listed)
- Age < 18 or > 35 yr
- Pre-existing diabetes
- Chronic medical conditions:
- Obstetric conditions:
- Medications known to affect lipid or glucose metabolism:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in neonatal adiposity by maternal Triglycerides, Glucose
Time frame: 14-16, 26-28 weeks gestation
Prediction of neonatal adiposity by maternal Triglycerides and Glucose
Change in maternal postprandial lipemia
Time frame: 26-28 weeks gestation
5 secondary outcomes
Change in maternal postprandial lipemia
Time frame: 14-16, 26-28 weeks gestation
Change in maternal postprandial glycemia
Time frame: 14-16, 26-28 weeks gestation
Prediction of neonatal adiposity by placental and maternal adipose tissue lipoprotein lipase (LPL) activity
Time frame: 26-28 weeks gestation
Correlation of neonatal adiposity and fetal growth
Time frame: 28-30 weeks gestation
Correlation of neonatal adiposity and fetal growth
Time frame: 36-37 weeks gestation
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 5 Nov 2019.
- Derived from this study: PubMed 29931812Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.
- 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.
Linda A Barbour, MD, MSPH principal investigator
University of Colorado, Denver
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 Gestational Diabetes, run by University of Colorado, Denver 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 4 inclusion and 26 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 5 Nov 2019. 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?
Change in neonatal adiposity by maternal Triglycerides, Glucose (time frame: 14-16, 26-28 weeks gestation). The study lists 2 primary outcomes in all. 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 NCT00826904, which also lists 1 linked publication.
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 5 Nov 2019.