Study of Placental Inflammation in Gestational Diabetes

March 18, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study of Placental Inflammation in Gestational Diabetes: the Role of the Inflammosome NLRP3 and the Scavenger Receptor of Inflammatory Chemokines D6

The aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to investigate systemic and placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6, compared to women with uncomplicated pregnancy

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

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

  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women with gestational diabetes mellitus
  • Women with uncomplicated pregnancy
  • Age >18 years
  • Singleton pregnancy

Exclusion Criteria:

  • Age < 18 years
  • Infections (HIV,HCV)
  • Multiple pregnancy
  • Cancer

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

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women with gestational diabetes mellitus
Blood and placenta sampling will be obtained from cases= women with gestational diabetes mellitus
Other: Blood samples for inflammatory markers
Blood sampling
Other: Placental Extract
Placental sampling after caesarean section
Experimental: Healthy women with uncomplicated pregnancy
Blood and placenta sampling will be obtained from controls= women with uncomplicated pregnancy
Other: Blood samples for inflammatory markers
Blood sampling
Other: Placental Extract
Placental sampling after caesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Placental inflammation
Time Frame: At delivery/birth
Analysis of protein expression of inflammasome NLRP3 and D6 scavenger receptor in placental tissue.
At delivery/birth

Collaborators and Investigators

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Chiara Tersigni, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

July 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4978

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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