Cologne Placenta Cohort (CPC)

June 17, 2022 updated by: Sarah Appel

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

247

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50931
        • University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Obstetrics deptartment of a University Hospital

Description

Inclusion Criteria:

  • singleton pregnancy
  • BMI before pregnancy >= 18
  • with & without gestational diabetes
  • c-section at gestational week 35+0 until 41+6

Exclusion Criteria:

  • multiple pregnancy
  • maternal serious internal disease
  • infections before pregnancy (e.g. HIV, hepatitis B)
  • pregnancy-associates diseases (e.g. gestoses, androgen insensitivity syndrome)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
normal weight without gestational diabetes
BMI < 25; normal glucose tolerance
Other: no intervention
no intervention
normal weight with gestational diabetes
BMI < 25; impaired oral glucose tolerance
Other: no intervention
no intervention
overweight without gestational diabetes
BMI 25 - 29.9; normal glucose tolerance
Other: no intervention
no intervention
overweight with gestational diabetes
BMI 25 - 29.9; impaired glucose tolerance
Other: no intervention
no intervention
obese without gestational diabetes
BMI >= 30; normal glucose tolerance
Other: no intervention
no intervention
obese with gestational diabetes
BMI >= 30; impaired glucose tolerance
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
through study completion, about 4 years in total

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarah Appel

Investigators

  • Principal Investigator: Sarah Appel, Dr., Universitatsklinikum Koln

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2018

Primary Completion (Actual)

November 6, 2020

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2022

Last Update Submitted That Met QC Criteria

June 17, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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