Diabetes, GestationalADIPOGESTNCT02905487
Relationship Between Gestational Diabetes Mellitus and Inflammatory Adipocytokins in Obese Mothers and Their Newborn at Delivery
An observational study of Diabetes, Gestational, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
Trial summary
ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Gestational
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mother-child pairs from obese women with GDM or not
Who may be able to join
- Pregnant women
- Obese women (BMI : 30 kg/m² or more)
- Aged over 18 years
- With single pregnancy
- With alive newborn at 37 weeks of amenorrhea or more
- With informed consent
Who cannot join
- Smoker
- Treatments by corticoïds or thyroid hormons
- Overt diabetes
- Complicated pregnancy
- Premature delivery threat
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Universitaire de La Réunion
Saint-Pierre, 97448
Olivier Maillard, PharmD, +262262359492, olivier.maillard@chu-reunion.fr
About this study
Official title: Relation Entre diabète Gestationnel et Adipocytokines Inflammatoires Chez Des mères obèses et Leur Nouveau-né à l'Accouchement
ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM)
Read the detailed description
ADIPOGEST is a cross sectional study in which mothers are divided into 2 groups : exposed and unexposed to GDM, matched on pregestational BMI, date of delivery and child gender.
Mothers are recruited in the maternity ward of the University Hospital in South of Reunion Island.
It is planned a conveniance sample of 20 mother-child pairs per group.
- Conditions
- Diabetes, Gestational
- Keywords
- Gestational Diabetes Mellitus, Obesity, Adipocytokin
- Medical subject headings
- Diabetes, Gestational, 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 |
|---|---|---|
| GDM | Mother-child pairs from mothers with GDM diagnosis (ADA, 2012) | |
| No GDM | Mother-child pairs from mothers without GDM diagnosis (ADA, 2012) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of leptin in mother and her child
Measured: 2 years
Blood levels of adiponectin in mother and her child
Measured: 2 years
Blood levels of IL-6 in mother and her child
Measured: 2 years
Blood levels of TNF-alpha in mother and her child
Measured: 2 years
Blood levels of C- Reactive Protein in mother and her child
Measured: 2 years
Secondary outcomes (1)
Blood level of C-peptide in mother
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905487
- Sponsor's protocol ID
- 2012/CHU/ADIPOGEST
- Acronym
- ADIPOGEST
- Status last verified
- Sep 2018
- First submitted
- 12 Sep 2016
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Entre diabète Gestationnel et Adipocytokines Inflammatoires Chez Des mères obèses et Leur Nouveau-né à l'Accouchement
- ClinicalTrials.gov ID
- NCT02905487
- Acronym / sponsor ID
- ADIPOGEST / 2012/CHU/ADIPOGEST
- Conditions
- Diabetes, Gestational
- Keywords
- Gestational Diabetes Mellitus, Obesity, Adipocytokin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 19 Sep 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.
ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM)
Detailed description
ADIPOGEST is a cross sectional study in which mothers are divided into 2 groups : exposed and unexposed to GDM, matched on pregestational BMI, date of delivery and child gender.
Mothers are recruited in the maternity ward of the University Hospital in South of Reunion Island.
It is planned a conveniance sample of 20 mother-child pairs per group.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM | – | –Mother-child pairs from mothers with GDM diagnosis (ADA, 2012) |
| No GDM | – | –Mother-child pairs from mothers without GDM diagnosis (ADA, 2012) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mother-child pairs from obese women with GDM or not
Key inclusion criteria (6 listed)
- Pregnant women
- Obese women (BMI : 30 kg/m² or more)
- Aged over 18 years
- With single pregnancy
- With alive newborn at 37 weeks of amenorrhea or more
Key exclusion criteria (5 listed)
- Smoker
- Treatments by corticoïds or thyroid hormons
- Overt diabetes
- Complicated pregnancy
- Premature delivery threat
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
Blood levels of leptin in mother and her child
Time frame: 2 years
Blood levels of adiponectin in mother and her child
Time frame: 2 years
Blood levels of IL-6 in mother and her child
Time frame: 2 years
Blood levels of TNF-alpha in mother and her child
Time frame: 2 years
Blood levels of C- Reactive Protein in mother and her child
Time frame: 2 years
1 secondary outcome
Blood level of C-peptide in mother
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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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.
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 Diabetes, Gestational, run by Centre Hospitalier Universitaire de la Réunion 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood levels of leptin in mother and her child (time frame: 2 years). The study lists 5 primary outcomes in all. 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 5 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.