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

September 4, 2018 updated by: Centre Hospitalier Universitaire de la Réunion

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

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)

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

40

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mother-child pairs from obese women with GDM or not

Description

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

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

Cohorts and Interventions

Group / Cohort
GDM
Mother-child pairs from mothers with GDM diagnosis (ADA, 2012)
No GDM
Mother-child pairs from mothers without GDM diagnosis (ADA, 2012)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood levels of leptin in mother and her child
Time Frame: 2 years
2 years
Blood levels of adiponectin in mother and her child
Time Frame: 2 years
2 years
Blood levels of IL-6 in mother and her child
Time Frame: 2 years
2 years
Blood levels of TNF-alpha in mother and her child
Time Frame: 2 years
2 years
Blood levels of C- Reactive Protein in mother and her child
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood level of C-peptide in mother
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de la Réunion

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)

January 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/CHU/ADIPOGEST

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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