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Metabolic Risk Following Gestational Diabetes Mellitus

NCT ID: NCT02133729

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-04-30

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.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Gestational diabete

Group Type EXPERIMENTAL

Blood sampling and OGTT

Intervention Type OTHER

Interventions

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Blood sampling and OGTT

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Bron, , France

Site Status

CHU Clermont-Ferrand - Hôpital Gabriel Montpied - Service d'endocrinologie

Clermont-Ferrand, , France

Site Status

Centre Hospitalier de Givors - Hôpital de Montgelas - Service de médicine 8

Givors, , France

Site Status

CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition

Grenoble, , France

Site Status

Hospices Civils de Lyon - Groupement Hospitalier Sud - Service d'Endocrinologie, Diabète, Nutrition

Pierre-Bénite, , France

Site Status

CHU Saint Etienne - Hôpital Nord - Service d'endocrinologie, diabètes, nutrition

Saint-Etienne, , France

Site Status

Groupement Hospitalier des Portes du Sud - Service d'Endocrinologie Diabétologie Nutrition

Vénissieux, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 25890778 (View on PubMed)

Other Identifiers

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2010.649

Identifier Type: -

Identifier Source: org_study_id