Metabolic Risk Following Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

— IMAGE  

Official title:

IMAGE (Metabolic Risk During Gestation) : Prospective Study of Women With Gestational Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133729
• Other study ID #: 2010.649
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: July 24, 2015
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Blood sampling and OGTT

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique	Bron
France	CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie	Clermont-ferrand
France	Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8	Givors
France	CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition	Grenoble
France	Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition	Pierre Benite
France	CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition	Saint Etienne
France	Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition	Venissieux

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of type 2 diabetes in women with GDM.	Prevalence of women with fasting blood glucose levels > 126mg/dl at 18 months (+/- 2 months) after delivery.	18 months (+/- 2 months) after delivery	No
Other	Adiponectin level		18 months (+/- 2 months) after delivery	No
Primary	Metabolic index value	The primary objective relies on Receiver Operating Characteristic (ROC) curves of metabolic index values using peripheral markers during gestation : C-Reactive Protein ultrasensitive (CRPus), malonaldehyde (MDA) and adiponectin (index = (CRP + MDA)/adiponectin) to detect an abnormal glucose tolerance at 3 months (+/- 15 days) after delivery (M3) during a 75g oral glucose tolerance test (T0>110mg/dl and/or T120 >145mg/dl). The rationale for the index relies on lower adiponectin values high CRPus levels and MDA values during insulin resistance chronic inflammatory status and oxidative stress.	3 months after delivery (+/- 15 days)	No
Secondary	Prevalence of abnormal glucose tolerance in women with GDM		3 months (+/- 15 days) following delivery	No