Obesity, MaternalNCT05424965
Cologne Placenta Cohort (CPC)
An observational study of Obesity, Maternal and Gestational Diabetes Mellitus in Pregnancy, run by Sarah Appel at 1 site in Germany.
Trial summary
Aim of the study was to determine if signaling pathways in placentas of mothers affected by overweight/obesity or by gestational diabetes are altered compared to placentas of a control group (normal weight, no gestational diabetes). Moreover, maternal blood and umbilical cord blood were analysed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity, Maternal, Gestational Diabetes Mellitus in Pregnancy
- Type of treatment
- Pill or oral medicine
- How many people
- 247 participants
- Where
- 1 siteGermany
- Study dates
- 23 Mar 2018to 31 Dec 2022
- 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: Obstetrics deptartment of a University Hospital
Who may be able to join
- singleton pregnancy
- BMI before pregnancy >= 18
- with \& without gestational diabetes
- c-section at gestational week 35+0 until 41+6
Who cannot join
- multiple pregnancy
- maternal serious internal disease
- infections before pregnancy (e.g. HIV, hepatitis B)
- pregnancy-associates diseases (e.g. gestoses, androgen insensitivity syndrome)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50931
About this study
Official title: Study to Investigate Signaling Pathways in Placentas of Overweight or Obese Patients and Patients With Gestational Diabetes Mellitus
Aim of the study was to determine if signaling pathways in placentas of mothers affected by overweight/obesity or by gestational diabetes are altered compared to placentas of a control group (normal weight, no gestational diabetes). Moreover, maternal blood and umbilical cord blood were analysed.
- Being tested
- no intervention
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| normal weight without gestational diabetes | BMI < 25; normal glucose tolerance Receives: Other: no intervention | |
| normal weight with gestational diabetes | BMI < 25; impaired oral glucose tolerance Receives: Other: no intervention | |
| overweight without gestational diabetes | BMI 25 - 29.9; normal glucose tolerance Receives: Other: no intervention | |
| overweight with gestational diabetes | BMI 25 - 29.9; impaired glucose tolerance Receives: Other: no intervention | |
| obese without gestational diabetes | BMI >= 30; normal glucose tolerance Receives: Other: no intervention | |
| obese with gestational diabetes | BMI >= 30; impaired glucose tolerance Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity of Wnt signaling pathway in placental tissue
Analysis of components of the Wnt signaling pathway; like LRP6 receptor, beta-Catenin, GSK3beta, Wnt ligands (=proteins of interest) and an appropriate protein for normalization.
Total protein lysates of placental tissue will be used. Analysis will be performed by western blotting and subsequent densitometric analysis. Outcome measure will be [relative protein level of protein or interest/relative protein level of normalization protein].
Measured: through study completion, about 4 years in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start23 Mar 2018
- Primary completion6 Nov 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MaternalStudies 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
- Retrospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Appel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Appel, Universitätsklinikum Köln
- Investigators
- Sarah Appel, Dr., Principal investigator, Universitätsklinikum Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424965
- Sponsor's protocol ID
- 14-244
- Status last verified
- Jun 2022
- First submitted
- 4 Jan 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate Signaling Pathways in Placentas of Overweight or Obese Patients and Patients With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05424965
- Acronym / sponsor ID
- 14-244
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Sarah AppelUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Jun 2022 (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.
Aim of the study was to determine if signaling pathways in placentas of mothers affected by overweight/obesity or by gestational diabetes are altered compared to placentas of a control group (normal weight, no gestational diabetes). Moreover, maternal blood and umbilical cord blood were analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| normal weight without gestational diabetes | – | Other: no interventionBMI < 25; normal glucose tolerance |
| normal weight with gestational diabetes | – | Other: no interventionBMI < 25; impaired oral glucose tolerance |
| overweight without gestational diabetes | – | Other: no interventionBMI 25 - 29.9; normal glucose tolerance |
| overweight with gestational diabetes | – | Other: no interventionBMI 25 - 29.9; impaired glucose tolerance |
| obese without gestational diabetes | – | Other: no interventionBMI >= 30; normal glucose tolerance |
| obese with gestational diabetes | – | Other: no interventionBMI >= 30; impaired glucose tolerance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Obstetrics deptartment of a University Hospital
Key inclusion criteria (4 listed)
- singleton pregnancy
- BMI before pregnancy >= 18
- with \& without gestational diabetes
- c-section at gestational week 35+0 until 41+6
Key exclusion criteria (4 listed)
- multiple pregnancy
- maternal serious internal disease
- infections before pregnancy (e.g. HIV, hepatitis B)
- pregnancy-associates diseases (e.g. gestoses, androgen insensitivity syndrome)
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 |
|---|---|---|
| no interventionno intervention | Other | normal weight with gestational diabetes, normal weight without gestational diabetes, obese with gestational diabetes, obese without gestational diabetes, overweight with gestational diabetes, overweight without gestational diabetes |
Primary outcome
Activity of Wnt signaling pathway in placental tissue
Time frame: through study completion, about 4 years in total
Analysis of components of the Wnt signaling pathway; like LRP6 receptor, beta-Catenin, GSK3beta, Wnt ligands (=proteins of interest) and an appropriate protein for normalization. Total protein lysates of placental tissue will be used. Analysis will be performed by western blotting and subsequent densitometric analysis. Outcome measure will be [relative protein level of protein or interest/relative protein level of normalization protein].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Sarah Appel, Dr. principal investigator
Universitätsklinikum Köln
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, Maternal and Gestational Diabetes Mellitus in Pregnancy, run by Sarah Appel at 1 site in Germany.
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 4 inclusion and 4 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 21 Jun 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 Germany. 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?
Activity of Wnt signaling pathway in placental tissue (time frame: through study completion, about 4 years in total). 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 21 Jun 2022; AzTrials last refreshed its copy on 27 Oct 2026.