Relationship Between Gestational Diabetes Mellitus and Inflammatory Adipocytokins in Obese Mothers and Their Newborn at Delivery

Diabetes, Gestational Clinical Trial

— ADIPOGEST  

Official title:

Relation Entre diabète Gestationnel et Adipocytokines Inflammatoires Chez Des mères obèses et Leur Nouveau-né à l'Accouchement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02905487
• Other study ID #: 2012/CHU/ADIPOGEST
• Status: Recruiting
• Start date: January 2016
• Est. completion date: June 2019

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

ADIPOGEST study aims at comparing circulating levels of inflammatory adipocytokins and C-reactive protein in obese women and their newborn at delivery whether exposed or not to Gestational Diabetes Mellitus (GDM)

Description:

ADIPOGEST is a cross sectional study in which mothers are divided into 2 groups : exposed and unexposed to GDM, matched on pregestational BMI, date of delivery and child gender.

Mothers are recruited in the maternity ward of the University Hospital in South of Reunion Island.

It is planned a conveniance sample of 20 mother-child pairs per group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women

• Obese women (BMI : 30 kg/m² or more)

• Aged over 18 years

• With single pregnancy

• With alive newborn at 37 weeks of amenorrhea or more

• With informed consent

Exclusion Criteria:

• Smoker

• Treatments by corticoïds or thyroid hormons

• Overt diabetes

• Complicated pregnancy

• Premature delivery threat

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational

Locations

Country	Name	City	State
France	Centre Universitaire de La Réunion	Saint Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood levels of leptin in mother and her child		2 years
Primary	Blood levels of adiponectin in mother and her child		2 years
Primary	Blood levels of IL-6 in mother and her child		2 years
Primary	Blood levels of TNF-alpha in mother and her child		2 years
Primary	Blood levels of C- Reactive Protein in mother and her child		2 years
Secondary	Blood level of C-peptide in mother		2 years