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Completed

NCT Number: NCT02133729

Metabolic Risk Following Gestational Diabetes Mellitus

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hôpital Femme-Mère-Enfant - Service de gynécologie obstétrique, Bron, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling and OGTT

Other

Primary outcomes

  1. Metabolic index value

    Time frame: 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 outcomes

  1. Prevalence of abnormal glucose tolerance in women with GDM

    Time frame: 3 months (+/- 15 days) following delivery

Other outcomes

  1. Prevalence of type 2 diabetes in women with GDM.

    Time frame: 18 months (+/- 2 months) after delivery

    Prevalence of women with fasting blood glucose levels > 126mg/dl at 18 months (+/- 2 months) after delivery.

  2. Adiponectin level

    Time frame: 18 months (+/- 2 months) after delivery

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: IMAGE

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 8, 2014
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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