Cologne Placenta Cohort (CPC)

• Sponsor: Sarah Appel (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05424965
• Collaborator: (none)
• Enrollment: 247
• Location: 1
• Anticipated Duration (Months): 57.3
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Maternal; Gestational Diabetes Mellitus in Pregnancy	Other: no intervention

Study Design

• Study Type: Observational
• Actual Enrollment: 247 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Study to Investigate Signaling Pathways in Placentas of Overweight or Obese Patients and Patients With Gestational Diabetes Mellitus
• Actual Study Start Date: Mar 23, 2018
• Actual Primary Completion Date: Nov 6, 2020
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Activity of Wnt signaling pathway in placental tissue [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].

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Cologne	Cologne	NRW	Germany	50931

Sponsors and Collaborators

• Sarah Appel

Investigators

• Principal Investigator: Sarah Appel, Dr., Universitätsklinikum Köln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Appel, Principal Investigator, Universitätsklinikum Köln
• ClinicalTrials.gov Identifier: NCT05424965
• Other Study ID Numbers: 14-244
• First Posted: Jun 21, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Obesity, Maternal; Diabetes Mellitus

Study Results

No Results Posted as of Jun 21, 2022