Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fonds de la Recherche en Santé du Québec
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Marie-France Hivert, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01623934
First received: June 18, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to:

  • assess the contribution and interactions of adipokines in the development of insulin resistance during pregnancy and gestational diabetes;
  • assess levels of maternal adipokines as determinants of development and fetal growth;
  • determine the genetic variations that influence levels of adipokines and glucose regulation during pregnancy and in newborns.

Condition
Gestational Diabetes
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of Adipokines in Glucose Regulation During Pregnancy and in Fetal Development

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Diagnosis of gestational diabetes mellitus [ Time Frame: 24-28 weeks of gestation ] [ Designated as safety issue: No ]
    75g oral glucose tolerance test


Biospecimen Retention:   Samples With DNA

plasma, whole cord blood, serum cord blood, white cells, sample of placenta


Estimated Enrollment: 1350
Study Start Date: January 2010
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pregnant women

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women when they come for their first prenatal visit at the Clinique de Prélèvements et de Recherche en Grossesse.

Criteria

Inclusion Criteria:

  • age ≥ 18 yrs
  • gestational age between 6 and 13 weeks from last menstrual period
  • no recognized diabetes or drugs interfering with glucose metabolism
  • alcohol < 2 drinks/day
  • not involved in regular high intensity physical activity
  • otherwise good health status

Exclusion Criteria:

  • twin pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623934

Locations
Canada, Quebec
Centre de recherche Étienne-Le Bel, Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H5N4
Sponsors and Collaborators
Université de Sherbrooke
Fonds de la Recherche en Santé du Québec
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Marie-France Hivert, MD, MSc Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Marie-France Hivert, Md, MMSc, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01623934     History of Changes
Other Study ID Numbers: DG2A1
Study First Received: June 18, 2012
Last Updated: December 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
Gestational diabetes
Adiponectin
Leptin
Single Nucleotides Polymorphisms
Insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Pregnancy Complications

ClinicalTrials.gov processed this record on July 26, 2014