NCT02905487

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

3.4 years

First QC Date

September 12, 2016

Last Update Submit

September 4, 2018

Conditions

Diabetes, Gestational

Keywords

Gestational Diabetes MellitusObesityAdipocytokin

Outcome Measures

Primary Outcomes (5)

  • 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 (1)

  • Blood level of C-peptide in mother

    2 years

Study Arms (2)

GDM

Mother-child pairs from mothers with GDM diagnosis (ADA, 2012)

No GDM

Mother-child pairs from mothers without GDM diagnosis (ADA, 2012)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mother-child pairs from obese women with GDM or not

You may qualify if:

  • 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

You may not qualify if:

  • Smoker
  • Treatments by corticoïds or thyroid hormons
  • Overt diabetes
  • Complicated pregnancy
  • Premature delivery threat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Universitaire de La Réunion

Saint-Pierre, 97448, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Leptin, adiponeptin, TNF-alpha, Interleukin-6, CRP and C-peptide blood levels

MeSH Terms

Conditions

Diabetes, GestationalObesity

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 19, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

FR(1)