PregnancyIMAGINENCT02926079
Investigation of Mechanisms for Transmission of Impaired Glucose Metabolism in Infants Exposed to Diabetes in Utero
An observational study of Pregnancy and Gestational Diabetes Mellitus, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This proposed study; Investigation of mechanisms for transmission of impaired glucose metabolism in infants exposed to diabetes in utero, will test the overarching hypothesis that impaired maternal substrate oxidation (metabolic inflexibility) and placental lipotoxicity are characteristics of diabetic pregnancies and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Gestational Diabetes Mellitus
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 8 Jan 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Up to 20 pregnant women with and without gestational diabetes mellitus with a BMI between 20 kg/m2 and 40 kg/m2 prior to the current pregnancy.
Who may be able to join
- BMI between 20 kg/m2 and 40 kg/m2 prior to the current pregnancy (determined by self-report and confirmation of pregravid BMI of the index pregnancy from the prenatal record)
- Completion of standardized glucose tolerance testing (between 24-28 weeks gestation) in the index pregnancy; either a single 2 hour, 75g glucose tolerance test or the two-step: 1 hour 50g and 3 hour 100g glucose tolerance test to confirm diagnosis of gestational diabetes mellitus or normal glucose tolerance
- Medically cleared for participation in the study by primary care obstetrician or midwife
- Medically cleared for participation by the Medical Investigator
- Medical record release (prenatal record, hospital delivery record) for study staff to access information in the medical record related to the current and if applicable, the prior pregnancy.
- Willingness to enroll the infant in the study provided inclusion/exclusion criteria pertaining to the infant are met
Show all 9Show fewer
- Born full-term (>37,0 weeks gestation)
- Available for clinical assessments between 10-30 days old
- Healthy
Who cannot join
- Use of insulin therapy in the index pregnancy
- History of preterm birth
- History of intrauterine growth-restriction
- Evidence of gestational hypertension (SBP >160 mmHg \& DBP >110 mmHg)
- HIV or AIDS (self-reported)
- Planned termination of pregnancy or adoption or unwillingness to enroll the infant in the study
Show all 9Show fewer
- Using medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence)
- Unwilling or unable to be fed 2 fl oz of infant formula
- Diagnosed with a congenital abnormality or disability that would render testing unsafe or would interfere with data collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
This proposed study; Investigation of mechanisms for transmission of impaired glucose metabolism in infants exposed to diabetes in utero, will test the overarching hypothesis that impaired maternal substrate oxidation (metabolic inflexibility) and placental lipotoxicity are characteristics of diabetic pregnancies and in utero development within these conditions programs a metabolically inflexible phenotype in the offspring.
Read the detailed description
This translational research study will obtain paired measures of metabolic flexibility (postprandial RQ minus basal RQ) in response to a standardized meal by indirect calorimetry in mother:infant dyads of diabetic and non-diabetic pregnancies. The downstream effects of the intrauterine exposure to diabetes and gestational lipotoxicity will be tested in the infant: 1) at birth by studying adipogenic pathways and mitochondrial function in umbilical cord mesenchymal stem cells cultured in myogenic conditions[13], and 2) by studying metabolic flexibility in the infant in a whole body infant calorimeter in response to a standardized meal.
Mothers will be enrolled between (33-35 weeks of gestation) and their infants will be enrolled between 10-30 days of life with the following aims.
Aim 1. Characterize metabolic flexibility and lipotoxicity in diabetic and non-diabetic pregnancies.
Hypothesis 1A: In response to a standardized meal in late pregnancy, diabetic pregnancies will be metabolically inflexible (blunted switch in RQ from the fasted state to the postprandial state) compared to non-diabetic pregnancies matched for maternal age and pregravid BMI.
Hypothesis 1B: Placenta from diabetic pregnancies will have higher lipid content, reduced mitochondrial content and lower rates of mitochondrial oxygen consumption compared to placenta from non-diabetic pregnancies.
Aim 2. Test whether intrauterine exposure to maternal diabetes infers disordered substrate oxidation in offspring at birth (in myocytes cultured from umbilical cord mesenchymal stem cells) and early in postnatal life (metabolic flexibility in response to a standardized meal).
Hypothesis 2A: Umbilical cord mesenchymal stem cells cultured in myogenic conditions from diabetic pregnancies will have greater lipid content, reduced mitochondrial content, and lower rates of mitochondrial electron transport oxygen consumption and fatty acid oxidation.
Hypothesis 2B: In response to a standardized meal, offspring of diabetic pregnancies will be metabolically inflexible (blunted switch in RQ from the pre- to postprandial state) compared to offspring of non-diabetic pregnancies.
- Conditions
- Pregnancy, Gestational Diabetes Mellitus
- Medical subject headings
- Diabetes, Gestational
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 |
|---|---|---|
| Pregnant women diagnosed with gestational diabetes | Not described | |
| Pregnant women with normal pregnancy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic flexibility - Mother
Assessed during a mixed-meal test as the difference in RQ between the postprandial period and the fasting period via indirect calorimetry.
Measured: One day
Secondary outcomes (5)
Metabolic Flexibility - Infant
Assessed during a standard infant formula test as the difference in RQ between the postprandial and the fasting period via indirect calorimetry.
Measured: One day
Lipid content in placenta samples
Lipid content will be measured in placenta samples via immunohistochemistry antibody staining for lipid droplet proteins and by Oil Red O staining.
Measured: One day (delivery)
Mitochondrial oxygen consumption rates in placenta samples
Oxygen consumption rates of isolated mitochondria from placenta will be measured by the SeaHorse device.
Measured: One day (delivery)
Fat content in umbilical cord mesenchymal stem cells
Mesenchymal stem cells will be differentiated to a myogenic state and assessed for lipid content via Oil Red O staining
Measured: One day (delivery)
Oxygen consumption rates in umbilical cord mesenchymal stem cells
Mesenchymal stem cells will be differentiated to a myogenic state and assessed for oxygen consumption rates using the Oroboros device.
Measured: One day (delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start23 May 2017
- Primary completion8 Nov 2018
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Leanne Redman, Pennington Biomedical Research Center
- Investigators
- Leanne M Redman, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926079
- Sponsor's protocol ID
- PBRC 2016-071
- Acronym
- IMAGINE
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2016
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Mechanisms for Transmission of Impaired Glucose Metabolism in Infants Exposed to Diabetes in Utero
- ClinicalTrials.gov ID
- NCT02926079
- Acronym / sponsor ID
- IMAGINE / PBRC 2016-071
- Conditions
- Pregnancy, Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 23 May 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 6 Oct 2016 (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.
This proposed study; Investigation of mechanisms for transmission of impaired glucose metabolism in infants exposed to diabetes in utero, will test the overarching hypothesis that impaired maternal substrate oxidation (metabolic inflexibility) and placental lipotoxicity are characteristics of diabetic pregnancies and in utero development within these conditions programs a metabolically inflexible phenotype in the offspring.
Detailed description
This translational research study will obtain paired measures of metabolic flexibility (postprandial RQ minus basal RQ) in response to a standardized meal by indirect calorimetry in mother:infant dyads of diabetic and non-diabetic pregnancies. The downstream effects of the intrauterine exposure to diabetes and gestational lipotoxicity will be tested in the infant: 1) at birth by studying adipogenic pathways and mitochondrial function in umbilical cord mesenchymal stem cells cultured in myogenic conditions[13], and 2) by studying metabolic flexibility in the infant in a whole body infant calorimeter in response to a standardized meal.
Mothers will be enrolled between (33-35 weeks of gestation) and their infants will be enrolled between 10-30 days of life with the following aims.
Aim 1. Characterize metabolic flexibility and lipotoxicity in diabetic and non-diabetic pregnancies.
Hypothesis 1A: In response to a standardized meal in late pregnancy, diabetic pregnancies will be metabolically inflexible (blunted switch in RQ from the fasted state to the postprandial state) compared to non-diabetic pregnancies matched for maternal age and pregravid BMI.
Hypothesis 1B: Placenta from diabetic pregnancies will have higher lipid content, reduced mitochondrial content and lower rates of mitochondrial oxygen consumption compared to placenta from non-diabetic pregnancies.
Aim 2. Test whether intrauterine exposure to maternal diabetes infers disordered substrate oxidation in offspring at birth (in myocytes cultured from umbilical cord mesenchymal stem cells) and early in postnatal life (metabolic flexibility in response to a standardized meal).
Hypothesis 2A: Umbilical cord mesenchymal stem cells cultured in myogenic conditions from diabetic pregnancies will have greater lipid content, reduced mitochondrial content, and lower rates of mitochondrial electron transport oxygen consumption and fatty acid oxidation.
Hypothesis 2B: In response to a standardized meal, offspring of diabetic pregnancies will be metabolically inflexible (blunted switch in RQ from the pre- to postprandial state) compared to offspring of non-diabetic pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women diagnosed with gestational diabetes | – | – |
| Pregnant women with normal pregnancy | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Up to 20 pregnant women with and without gestational diabetes mellitus with a BMI between 20 kg/m2 and 40 kg/m2 prior to the current pregnancy.
Key inclusion criteria (9 listed)
- BMI between 20 kg/m2 and 40 kg/m2 prior to the current pregnancy (determined by self-report and confirmation of pregravid BMI of the index pregnancy from the prenatal record)
- Completion of standardized glucose tolerance testing (between 24-28 weeks gestation) in the index pregnancy; either a single 2 hour, 75g glucose tolerance test or the two-step: 1 hour 50g and 3 hour 100g glucose tolerance test to confirm diagnosis of gestational diabetes mellitus or normal glucose tolerance
- Medically cleared for participation in the study by primary care obstetrician or midwife
- Medically cleared for participation by the Medical Investigator
- Medical record release (prenatal record, hospital delivery record) for study staff to access information in the medical record related to the current and if applicable, the prior pregnancy.
Key exclusion criteria (9 listed)
- Use of insulin therapy in the index pregnancy
- History of preterm birth
- History of intrauterine growth-restriction
- Evidence of gestational hypertension (SBP >160 mmHg \& DBP >110 mmHg)
- HIV or AIDS (self-reported)
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
Metabolic flexibility - Mother
Time frame: One day
Assessed during a mixed-meal test as the difference in RQ between the postprandial period and the fasting period via indirect calorimetry.
5 secondary outcomes
Metabolic Flexibility - Infant
Time frame: One day
Lipid content in placenta samples
Time frame: One day (delivery)
Mitochondrial oxygen consumption rates in placenta samples
Time frame: One day (delivery)
Fat content in umbilical cord mesenchymal stem cells
Time frame: One day (delivery)
Oxygen consumption rates in umbilical cord mesenchymal stem cells
Time frame: One day (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 27 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
Leanne M Redman, PhD principal investigator
Pennington Biomedical Research 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 Pregnancy and Gestational Diabetes Mellitus, run by Pennington Biomedical Research 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 9 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: finished, as of the sponsor's last update on 27 Sep 2022. 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?
Metabolic flexibility - Mother (time frame: One day). 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 27 Sep 2022.