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NCT05424965 Clinical Trial

Cologne Placenta Cohort (CPC)

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:
Study to Investigate Signaling Pathways in Placentas of Overweight or Obese Patients and Patients With Gestational Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05424965
Other study ID # 14-244
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 23, 2018
Est. completion date December 31, 2022

Study information
Verified date June 2022
Source Universitätsklinikum Köln
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 247
Est. completion date December 31, 2022
Est. primary completion date November 6, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• no intervention
no intervention

Locations
Country Name City State
Germany University Hospital of Cologne Cologne NRW

Sponsors (1)
Lead Sponsor Collaborator
Sarah Appel

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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].		 through study completion, about 4 years in total
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