Metabolic Risk Following Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Other: Blood sampling and OGTT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gestational diabete<br> | Other: Blood sampling and OGTT<br> <br> |

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of abnormal glucose tolerance in women with GDM |  | 3 months (+/- 15 days) following delivery |