Study of Placental Inflammation in Gestational Diabetes

Not Applicable

Active, not recruiting

• Conditions: Gestational Diabetes Mellitus (GDM)

• Registration Number: NCT06884696
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

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 Timeline

• Study Start: 2022-07-01
• Primary Completion: 2023-06-30
• Status Verified: 2024-06
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Placental inflammation	At delivery/birth	Analysis of protein expression of inflammasome NLRP3 and D6 scavenger receptor in placental tissue.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy