Gestational Diabetes
Conditions
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.
Interventions
OTHERBlood sampling and OGTT
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic index value | 3 months after delivery (+/- 15 days) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of abnormal glucose tolerance in women with GDM | 3 months (+/- 15 days) following delivery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of type 2 diabetes in women with GDM. | 18 months (+/- 2 months) after delivery | Prevalence of women with fasting blood glucose levels \> 126mg/dl at 18 months (+/- 2 months) after delivery. |
| Adiponectin level | 18 months (+/- 2 months) after delivery | — |
Countries
France
Outcome results
None listed