Clinical trial NCT02133729: Metabolic Risk Following Gestational Diabetes Mellitus
Official title: IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 255
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Gestational diabetes (GDM) is defined by abnormal glucose tolerance during gestation. This complication occurs in 4-10% and is associated with fetal complications and macrosomia. In addition, women with GDM have an increased risk to develop type 2 diabetes after delivery. Despite recommendations, it is difficult to follow-up all women with GDM during the postpartum period due to high numbers of subjects that exceed usual healthcare resources. It is therefore necessary to focus clinical attention toward women at high risk of type 2 diabetes in order to set adequate preventive strategies.


Eligibility criteria: Inclusion Criteria:

* Women aged over 18years old
* Women with the criteria of GDM during pregnancy at 21-35 weeks of gestation (one situation):

  * After a 75g Oral Glucose Tolerance Test (OGTT - WHO criteria) with blood glucose (BG) values at T60≥180mg/dl and/or T120≥153mg/dl
  * An O. Sullivan test following a 100g oral glucose load with at least two pathological values (T60 ≥ 180mg/dl and/or T120 ≥ 155mg/dl and/or T180 ≥ 140mg/dl)
  * With a fasting BG value ≥92mg/dl
* Women with signed informed consent

Exclusion Criteria:

* Women aged less than 18years old
* Women with pregestational type 2 diabetes
* Women without signed informed consent
* Women who does not read and/or understand french language
* Women not affiliated to the health care system
* Women with recent infection (\<1month) and/or on steroids or anti-inflammatory drugs.
* Women with chronic diseases
* Women with a disable state
* Women with normal glucose tolerance
* Women already incorporated in another clinical study that could interfere with the present study

Primary outcomes:
measure: Metabolic index value
timeFrame: 3 months after delivery (+/- 15 days)
Secondary outcomes:
measure: Prevalence of abnormal glucose tolerance in women with GDM
timeFrame: 3 months (+/- 15 days) following delivery
Other outcomes:
measure: Prevalence of type 2 diabetes in women with GDM.
timeFrame: 18 months (+/- 2 months) after delivery
measure: Adiponectin level
timeFrame: 18 months (+/- 2 months) after delivery
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique
city: Clermont-ferrand
country: France
facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie
city: Givors
country: France
facility: Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8
city: Grenoble
country: France
facility: CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition
city: Saint Etienne
country: France
facility: CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition
city: Venissieux
country: France
facility: Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition
Study officials:
References: