ObesityOB-APENCT02796456
Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
An observational study of Obesity and Pregnancy, run by University Hospital, Lille at 1 site in France.
Trial summary
Background : Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Obesity, Pregnancy, Gestational Diabetes
- What is being tested?
- blood sample
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Apr 2018
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Women between 18 and 42 years old, pregnant, between 35 and 40 WG.
Who may be able to join
- Obese pregnant women
- Age from 18 to 42 years old
- Singleton pregnancy between 35+0 to 41+6 weeks of pregnancy
Who cannot join
- Severe heart, liver or kidney disease
- Multiple pregnancy
- Hypertension, preeclampsia, small for gestational age
- Pre-gestational diabetes
- Bariatric surgery
- Medication other than normal pregnancy supplementations
Show all 14Show fewer
- Tabacco or drugs consummation during pregnancy
- Provided artificial feeding
- Fetal anoxia with cord pH less than 7.0
- Genetic or chromosomal mother's and / or newborn's abnormality
- Fetal malformation
- Trusteeship or tutorship
- Refusal to participate in research
- Unable to attend the entire study
Trial locations and contacts
1 site in 1 country.
About this study
Background :
Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation.
Read more
Objective :
The main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).
Strategy and method:
A prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).
A third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes).
Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.
Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta.
Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.
Two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.
Read the detailed description
Background :
Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity.
Little is known about the function of the apelinergic system during gestation.
In a previous study, investigators evaluated in mice this system at the feto-maternal interface in insulin-resistant obese female (HF) mice. Maternal apelinemia was decreased at term and fetal apelinemia was sixfold higher than maternal level. Ex-vivo, the placenta releases high amount of apelin at E12.5 and E18.5. In HF pregnant mice at term, apelinemia as well as placental apelin and APJ mRNA levels were increased whereas placental release of apelin was drastically reduced.
- Conditions
- Obesity, Pregnancy, Gestational Diabetes
- Being tested
- blood sample
- Keywords
- apelin, colostrum, plasma, glycemic markers, lipidic markers, pregnancy, postpartum
- Medical subject headings
- Obesity, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Normal weight women | BMI between 18.5 and 25 kg/m2 and without gestational diabetes Receives: Other: blood sample | |
| Obese women without gestational diabetes | BMI more than 30 kg/m2 and without gestational diabetes Receives: Other: blood sample | |
| Obese women with gestational diabetes | BMI more than 30 kg/m2 and with gestational diabetes Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological measure : Maternal apelinemia (Plasma Concentration)
plasma sample
Measured: between 35 and 41 weeks of gestation (WG)
Secondary outcomes (25)
Biological measure : Neonatal apelinemia (Plasma Concentration)
plasma sample
Measured: the day of the delivery
Biological measure : Maternal apelinemia (Plasma Concentration)
plasma sample
Measured: the day of the delivery and 2 days after the delivery
apelin level in the colostrum
colostrum sample
Measured: 2 days after the delivery
C-peptide
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
glycemia
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
insulinemia
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
C-peptide
neonatal plasma sample
Measured: the day of the delivery
glycemia
neonatal plasma sample
Measured: the day of the delivery
insulinemia
neonatal plasma sample
Measured: the day of the delivery
total cholesterol
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
HDL
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
LDL
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
triglycerides
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
apolipoprotein A
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
apolipoprotein B
maternal plasma sample
Measured: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
total cholesterol
neonatal plasma sample
Measured: the day of the delivery
Biological measure : HDL
neonatal plasma sample
Measured: the day of the delivery
Biological measure : LDL
neonatal plasma sample
Measured: the day of the delivery
triglycerides
neonatal plasma sample
Measured: the day of the delivery
apolipoprotein A
neonatal plasma sample
Measured: the day of the delivery
apolipoprotein B
neonatal plasma sample
Measured: the day of the delivery
BMI
measure maternal gain of weight before pregnancy and during pregnancy in maternal declaration
Measured: at baseline
Infant weight
Measured: within 2 days of postpartum
Infant size
Measured: within 5 days of postpartum
Placenta weight
Measured: the days of the delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Deruelle, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796456
- Sponsor's protocol ID
- 2014_70
- Other IDs
- 2015-A01696-43
- Acronym
- OB-APE
- Status last verified
- Jun 2018
- First submitted
- 19 May 2016
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy
- ClinicalTrials.gov ID
- NCT02796456
- Acronym / sponsor ID
- OB-APE / 2014_70
- Conditions
- Obesity, Pregnancy, Gestational Diabetes
- Keywords
- apelin, colostrum, plasma, glycemic markers, lipidic markers, pregnancy, postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 10 Jun 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.
Background :
Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation.
Objective :
The main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).
Strategy and method:
A prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG).
A third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes).
Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers.
Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta.
Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group.
Two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.
Detailed description
Background :
Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity.
Little is known about the function of the apelinergic system during gestation.
In a previous study, investigators evaluated in mice this system at the feto-maternal interface in insulin-resistant obese female (HF) mice. Maternal apelinemia was decreased at term and fetal apelinemia was sixfold higher than maternal level. Ex-vivo, the placenta releases high amount of apelin at E12.5 and E18.5. In HF pregnant mice at term, apelinemia as well as placental apelin and APJ mRNA levels were increased whereas placental release of apelin was drastically reduced.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal weight women | – | Other: blood sampleBMI between 18.5 and 25 kg/m2 and without gestational diabetes |
| Obese women without gestational diabetes | – | Other: blood sampleBMI more than 30 kg/m2 and without gestational diabetes |
| Obese women with gestational diabetes | – | Other: blood sampleBMI more than 30 kg/m2 and with gestational diabetes |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women between 18 and 42 years old, pregnant, between 35 and 40 WG.
Key inclusion criteria (3 listed)
- Obese pregnant women
- Age from 18 to 42 years old
- Singleton pregnancy between 35+0 to 41+6 weeks of pregnancy
Key exclusion criteria (14 listed)
- Severe heart, liver or kidney disease
- Multiple pregnancy
- Hypertension, preeclampsia, small for gestational age
- Pre-gestational diabetes
- Bariatric surgery
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 |
|---|---|---|
| blood sample | Other | Normal weight women, Obese women with gestational diabetes, Obese women without gestational diabetes |
Primary outcome
Biological measure : Maternal apelinemia (Plasma Concentration)
Time frame: between 35 and 41 weeks of gestation (WG)
plasma sample
25 secondary outcomes
Biological measure : Neonatal apelinemia (Plasma Concentration)
Time frame: the day of the delivery
Biological measure : Maternal apelinemia (Plasma Concentration)
Time frame: the day of the delivery and 2 days after the delivery
apelin level in the colostrum
Time frame: 2 days after the delivery
C-peptide
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
glycemia
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
insulinemia
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
C-peptide
Time frame: the day of the delivery
glycemia
Time frame: the day of the delivery
insulinemia
Time frame: the day of the delivery
total cholesterol
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
HDL
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
LDL
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
triglycerides
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
apolipoprotein A
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
apolipoprotein B
Time frame: between 35 and 41 weeks of gestation (WG) and 2 days after the delivery
total cholesterol
Time frame: the day of the delivery
Biological measure : HDL
Time frame: the day of the delivery
Biological measure : LDL
Time frame: the day of the delivery
triglycerides
Time frame: the day of the delivery
apolipoprotein A
Time frame: the day of the delivery
apolipoprotein B
Time frame: the day of the delivery
BMI
Time frame: at baseline
Infant weight
Time frame: within 2 days of postpartum
Infant size
Time frame: within 5 days of postpartum
Placenta weight
Time frame: the days of the 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 13 Jun 2018.
- 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.
Philippe Deruelle, MD, PhD principal investigator
University Hospital, Lille
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 Obesity and Pregnancy, run by University Hospital, Lille at 1 site in France.
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 14 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 13 Jun 2018. 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 France. 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?
Biological measure : Maternal apelinemia (Plasma Concentration) (time frame: between 35 and 41 weeks of gestation (WG)). 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 13 Jun 2018.