Gestational DiabetesGaPNCT05872009
Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health"
An observational study of Gestational Diabetes and Cardiovascular Diseases, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The GaP study is designed to close important knowledge gaps by: 1. exploring placental health and cellular ageing in GDM and the association with neonatal outcome 2. evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Cardiovascular Diseases, Placenta Diseases
- How many people
- 350 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jun 2023to Jun 2026
- 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
- Adult, Older adult
Study population: Pregnant women with GDM (diagnosed according to guidelines and referred to our outpatient clinic) and healthy, euglycemic pregnant women (Control group: referred for breech evaluation, planning of elective cesarean section, suspected reduced or increased fetal growth with a normal finding at ultrasound). Patients can be recruited from outpatient clinic, prior to induction, at admission for elective cesaerean section or at admission for labor (but not yet in active labor)
Who may be able to join
- Pregnant women >18 years with GDM giving birth at Oslo University hospital Ullevål.
- Control group of gestational age matched euglycemic, normotensive pregnancies
Who cannot join
- reduced fetal movements,
- epilepsy
- thyroidea dysfunction
- hypertensive disorder of pregnancy
- non-communicable disease
- Communicable disease (such as HIV)
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- type 1 or type 2 diabetes.
- not able to understand Norwegian or English.
- under legal guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The GaP Study: Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health
The GaP study is designed to close important knowledge gaps by:
- exploring placental health and cellular ageing in GDM and the association with neonatal outcome
- evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM
Read the detailed description
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM has potential adverse short and long term health effects for both the women and her offspring, and involves dysfunctional interaction between placenta and the maternal body. The burden for the individual, the health system and society warrants further investigations into the placental-maternal crosstalk in GDM in order to improve personalized pregnancy surveillance and follow-up. In Oslo county, nearly twice as many women who give birth suffer from GDM (5.7%) than from preeclampsia (2.3%). The large obstetric department at Ullevål provides an optimal environment for novel translational studies and clinical practical aspects of GDM. The GaP study is designed to close important knowledge gaps by:
- exploring placental health and cellular ageing in GDM and the association with neonatal outcome
- evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM
- Medical subject headings
- Diabetes, Gestational, Cardiovascular Diseases, Placenta Diseases
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 |
|---|---|---|
| Women with gestational diabetes | Any treatment. N=200. | |
| Control group | Gestational-age matched, euglycemic, normotensive pregnant women (n=150) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women with altered levels of circulating senescence markers
Levels of maternal circulating senescence markers, e.g. SAA1, free thiol and related markers, in case group compared to controls
Measured: 4 years
Number of women with altered levels of tissue-based senescence markers
Expression of markers of senescence in placental tissue, as assesed by immunohistochemistry (e.g. IL-6, p21, p16 and related markers) in case group compared to controls
Measured: 4 years
Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function
As assessed by circulating maternal levels of cardiovascular biomarkers, e.g. HDL (mmol/l), LDL (mmol/l) and related markers in case group compared to controls
Measured: 4 years
Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function
As assessed by circulating maternal levels of cardiovascular biomarkers, e.g. GDF-15 (ng/l), NT-pro BNP (ng/l), Troponin (ng/l) and related markers in case group compared to controls
Measured: 4 years
Number of neonates with adverse neonatal outcome
A composite measure for neonatal outcome will be created using information on fetal acidemia, Apgar-score, asphyxia, intra-/postpartum fetal death, neonatal intubation/mechanical ventilation, meconium aspiration syndrome, netonatal hypoxic-ishcemic encephalopathy, therapeutic hypothermia of the neonate, rate of acute cesarean section (due to suspected fetal distress) and compared in case group and controls
Measured: 4 years
Secondary outcomes (2)
Number of participants with operative vaginal delivery due to suspected fetal distress
Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress) in case and control groups
Measured: 4 years
Percentage of participants with pathological placenta histology findings in case and control groups
As assessed by a senior perinatal pathologist using predefined criteria
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian SIDS and Stillbirth Society
- Responsible party
- Principal investigator, Meryam Sugulle, Oslo University Hospital
- Investigators
- Meryam Sugulle, PhD, Principal investigator, Oslo University Hospital, Division of Gynaecology and Obstetrics, Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872009
- Sponsor's protocol ID
- 494097
- Acronym
- GaP
- Status last verified
- May 2023
- First submitted
- 8 Mar 2023
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on when the permission for the dataset usage for the project's outcome measures ends (OUH personal data officer/Regional Ethical Comittee) AND Norwegian legislation regarding personal data protection. It is unlikely that a major part of the data set will be shared openly due to these restrictions on sensitive personal data matters.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GaP Study: Gestational Diabetes Mellitus: "Placental-maternal Crosstalk and Future Health
- ClinicalTrials.gov ID
- NCT05872009
- Acronym / sponsor ID
- GaP / 494097
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian SIDS and Stillbirth Society
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 May 2023 (actual)
- 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 GaP study is designed to close important knowledge gaps by:
- exploring placental health and cellular ageing in GDM and the association with neonatal outcome
- evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM
Detailed description
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM has potential adverse short and long term health effects for both the women and her offspring, and involves dysfunctional interaction between placenta and the maternal body. The burden for the individual, the health system and society warrants further investigations into the placental-maternal crosstalk in GDM in order to improve personalized pregnancy surveillance and follow-up. In Oslo county, nearly twice as many women who give birth suffer from GDM (5.7%) than from preeclampsia (2.3%). The large obstetric department at Ullevål provides an optimal environment for novel translational studies and clinical practical aspects of GDM. The GaP study is designed to close important knowledge gaps by:
- exploring placental health and cellular ageing in GDM and the association with neonatal outcome
- evaluating the effectiveness of current and novel maternal health follow-up strategies after GDM
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with gestational diabetes | – | –Any treatment. N=200. |
| Control group | – | –Gestational-age matched, euglycemic, normotensive pregnant women (n=150) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with GDM (diagnosed according to guidelines and referred to our outpatient clinic) and healthy, euglycemic pregnant women (Control group: referred for breech evaluation, planning of elective cesarean section, suspected reduced or increased fetal growth with a normal finding at ultrasound). Patients can be recruited from outpatient clinic, prior to induction, at admission for elective cesaerean section or at admission for labor (but not yet in active labor)
Key inclusion criteria (2 listed)
- Pregnant women >18 years with GDM giving birth at Oslo University hospital Ullevål.
- Control group of gestational age matched euglycemic, normotensive pregnancies
Key exclusion criteria (9 listed)
- reduced fetal movements,
- epilepsy
- thyroidea dysfunction
- hypertensive disorder of pregnancy
- non-communicable disease
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
Number of women with altered levels of circulating senescence markers
Time frame: 4 years
Levels of maternal circulating senescence markers, e.g. SAA1, free thiol and related markers, in case group compared to controls
Number of women with altered levels of tissue-based senescence markers
Time frame: 4 years
Expression of markers of senescence in placental tissue, as assesed by immunohistochemistry (e.g. IL-6, p21, p16 and related markers) in case group compared to controls
Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function
Time frame: 4 years
As assessed by circulating maternal levels of cardiovascular biomarkers, e.g. HDL (mmol/l), LDL (mmol/l) and related markers in case group compared to controls
Number of women with increased values for postpartum surrogate markers for impaired cardiovascular function
Time frame: 4 years
As assessed by circulating maternal levels of cardiovascular biomarkers, e.g. GDF-15 (ng/l), NT-pro BNP (ng/l), Troponin (ng/l) and related markers in case group compared to controls
Number of neonates with adverse neonatal outcome
Time frame: 4 years
A composite measure for neonatal outcome will be created using information on fetal acidemia, Apgar-score, asphyxia, intra-/postpartum fetal death, neonatal intubation/mechanical ventilation, meconium aspiration syndrome, netonatal hypoxic-ishcemic encephalopathy, therapeutic hypothermia of the neonate, rate of acute cesarean section (due to suspected fetal distress) and compared in case group and controls
2 secondary outcomes
Number of participants with operative vaginal delivery due to suspected fetal distress
Time frame: 4 years
Percentage of participants with pathological placenta histology findings in case and control groups
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: Undecided. Depending on when the permission for the dataset usage for the project's outcome measures ends (OUH personal data officer/Regional Ethical Comittee) AND Norwegian legislation regarding personal data protection. It is unlikely that a major part of the data set will be shared openly due to these restrictions on sensitive personal data matters.
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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.
Meryam Sugulle, PhD principal investigator
Oslo University Hospital, Division of Gynaecology and Obstetrics, Ullevål
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 Cardiovascular Diseases, run by Oslo University Hospital at 1 site in Norway.
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 2 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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 Norway. 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?
Contact Meryam Sugulle, PhD (+47 22119800, UXSUME@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women with altered levels of circulating senescence markers (time frame: 4 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 23 May 2023.