Metabolic Risk Following Gestational Diabetes Mellitus (IMAGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Blood sampling and OGTT

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie
  • Givors, France, 69700
    • Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8
  • Grenoble, France, 38000
    • CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition
  • Saint-Etienne, France, 42055
    • CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition
  • Vénissieux, France, 69200
    • Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gestational diabete	Other: Blood sampling and OGTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence of abnormal glucose tolerance in women with GDM	3 months (+/- 15 days) following delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adiponectin level		18 months (+/- 2 months) after delivery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Honnorat D, Disse E, Millot L, Mathiotte E, Claret M, Charrie A, Drai J, Garnier L, Maurice C, Durand E, Simon C, Dupuis O, Thivolet C. Are third-trimester adipokines associated with higher metabolic risk among women with gestational diabetes? Diabetes Metab. 2015 Nov;41(5):393-400. doi: 10.1016/j.diabet.2015.03.003. Epub 2015 Apr 15.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 25, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimated): May 8, 2014

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Blood Specimen Collection; Glucose Tolerance Test
• Other Study ID Numbers: 2010.649