Relationship Between Gestational Diabetes Mellitus and In... | NCT02905487

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

NCT02905487

Sponsor

Centre Hospitalier Universitaire de la Réunion

Status

Unknown status

Last Update Posted

Sep 5, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Diabetes, Gestational

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

Sep 14, 2016

First Posted Date

Sep 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2018

Last Update Posted Date

Sep 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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)

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GDM		Mother-child pairs from mothers with GDM diagnosis (ADA, 2012)
No GDM		Mother-child pairs from mothers without GDM diagnosis (ADA, 2012)

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Mother-child pairs from obese women with GDM or not

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Universitaire de La Réunion	Recruiting	Saint-Pierre		97448	France

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational
D009765	Obesity

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided