Gestational DiabetesGEN3GNCT01623934
Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development
An observational study of Gestational Diabetes and Insulin Resistance, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
This study includes 2 phases. During phase 1, pregnant women are followed over the course of pregnancy. The phase 2 is a follow-up of the mother-child dyad at 3, 5 and 10-12 year after delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Insulin Resistance, Obesity Prevention
- How many people
- 1,034 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Sep 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Phase 1: Pregnant women when they come for their first prenatal visit at the Clinique de Prélèvements et de Recherche en Grossesse. Phase 2: mothers and their child
Who may be able to join
- age ≥ 18 yrs
- gestational age between 6 and 13 weeks from last menstrual period
- no recognized diabetes or drugs interfering with glucose metabolism
- alcohol < 2 drinks/day
- not involved in regular high intensity physical activity
- otherwise good health status
Who cannot join
- twin pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5N4
About this study
This study includes 2 phases. During phase 1, pregnant women are followed over the course of pregnancy. The phase 2 is a follow-up of the mother-child dyad at 3, 5 and 10-12 year after delivery.
The purpose of this phase 1 is to :
Read more
- assess the contribution and interactions of adipokines in the development of insulin resistance during pregnancy and gestational diabetes;
- assess levels of maternal adipokines as determinants of development and fetal growth;
- determine the genetic variations that influence levels of adipokines and glucose regulation during pregnancy and in newborns.
The purpose of this phase 2 is to:
- identify DNA methylation variations at birth that are predictive of childhood overweight/obesity.
- identify maternal characteristics associated with DNA methylation variations predictive of childhood overweight/obesity.
- establish whether the loci predictive of childhood overweight/obesity at birth are still differentially methylated at 5 years of age (samples collected at 5 years of age).
- identify DNA methylation variations at birth that are predictive of childhood neurodevelopment problems at 3, 5 and 10 years of age.
- Conditions
- Gestational Diabetes, Insulin Resistance, Obesity Prevention
- Keywords
- Gestational diabetes, Adiponectin, Leptin, Single Nucleotides Polymorphisms, Insulin resistance, obesity
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance, 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 |
|---|---|---|
| Phase 1: Pregnant women | Not described | |
| Phase 2: Mother-offspring dyad | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of gestational diabetes mellitus
75g oral glucose tolerance test
Measured: 24-28 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
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 Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Canadian Institutes of Health Research (CIHR), American Diabetes Association, Diabetes Québec
- Responsible party
- Principal investigator, Marie-France Hivert, Université de Sherbrooke
- Investigators
- Marie-France Hivert, MD, MSc, Principal investigator, Harvard Medical School, Harvard Prilgrim Health Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623934
- Sponsor's protocol ID
- GEN3G
- Acronym
- GEN3G
- Status last verified
- Oct 2024
- First submitted
- 18 Jun 2012
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guillemette L, Allard C, Lacroix M, Patenaude J, Battista MC, Doyon M, Moreau J, Menard J, Bouchard L, Ardilouze JL, Perron P, Hivert MF. Genetics of Glucose regulation in Gestation and Growth (Gen3G): a prospective prebirth cohort of mother-child pairs in Sherbrooke, Canada. BMJ Open. 2016 Feb 3;6(2):e010031. doi: 10.1136/bmjopen-2015-010031.
PubMed 26842272
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development
- ClinicalTrials.gov ID
- NCT01623934
- Acronym / sponsor ID
- GEN3G / GEN3G
- Conditions
- Gestational Diabetes, Insulin Resistance, Obesity Prevention
- Keywords
- Gestational diabetes, Adiponectin, Leptin, Single Nucleotides Polymorphisms, Insulin resistance, obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, Canadian Institutes of Health Research (CIHR), American Diabetes Association, Diabetes Québec
- Study start
- Jan 2010
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 Jun 2012 (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 study includes 2 phases. During phase 1, pregnant women are followed over the course of pregnancy. The phase 2 is a follow-up of the mother-child dyad at 3, 5 and 10-12 year after delivery.
The purpose of this phase 1 is to :
- assess the contribution and interactions of adipokines in the development of insulin resistance during pregnancy and gestational diabetes;
- assess levels of maternal adipokines as determinants of development and fetal growth;
- determine the genetic variations that influence levels of adipokines and glucose regulation during pregnancy and in newborns.
The purpose of this phase 2 is to:
- identify DNA methylation variations at birth that are predictive of childhood overweight/obesity.
- identify maternal characteristics associated with DNA methylation variations predictive of childhood overweight/obesity.
- establish whether the loci predictive of childhood overweight/obesity at birth are still differentially methylated at 5 years of age (samples collected at 5 years of age).
- identify DNA methylation variations at birth that are predictive of childhood neurodevelopment problems at 3, 5 and 10 years of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Pregnant women | – | – |
| Phase 2: Mother-offspring dyad | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Phase 1: Pregnant women when they come for their first prenatal visit at the Clinique de Prélèvements et de Recherche en Grossesse. Phase 2: mothers and their child
Key inclusion criteria (6 listed)
- age ≥ 18 yrs
- gestational age between 6 and 13 weeks from last menstrual period
- no recognized diabetes or drugs interfering with glucose metabolism
- alcohol < 2 drinks/day
- not involved in regular high intensity physical activity
Key exclusion criteria (1 listed)
- twin pregnancy
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
Diagnosis of gestational diabetes mellitus
Time frame: 24-28 weeks of gestation
75g oral glucose tolerance test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 26842272Guillemette L, Allard C, Lacroix M, Patenaude J, Battista MC, Doyon M, Moreau J, Menard J, Bouchard L, Ardilouze JL, Perron P, Hivert MF. Genetics of Glucose regulation in Gestation and Growth (Gen3G): a prospective prebirth cohort of mother-child pairs in Sherbrooke, Canada. BMJ Open. 2016 Feb 3;6(2):e010031. doi: 10.1136/bmjopen-2015-010031.
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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.
Marie-France Hivert, MD, MSc principal investigator
Harvard Medical School, Harvard Prilgrim Health Care Institute
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 Gestational Diabetes and Insulin Resistance, run by Université de Sherbrooke at 1 site in Canada.
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 1 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 18 Oct 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 Canada. 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?
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?
Diagnosis of gestational diabetes mellitus (time frame: 24-28 weeks of gestation). 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 NCT01623934, 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 18 Oct 2024.