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Metabolic Risk Following Gestational Diabetes Mellitus (IMAGE)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Gestational Diabetes

Treatments

Other: Blood sampling and OGTT

Study type

Interventional

Funder types

Other

Identifiers

NCT02133729
2010.649

Details and patient eligibility

About

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.

Enrollment

255 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

255 participants in 1 patient group

Gestational diabete
Experimental group
Treatment:
Other: Blood sampling and OGTT

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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