Metabolic Risk Following Gestational Diabetes Mellitus

NCT02133729 | Completed DMC

• 1 other identifier: 2010.649
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 7

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prevalence of abnormal glucose tolerance in women with GDM

  3 months (+/- 15 days) following delivery

Other Outcomes (2)

• Prevalence of type 2 diabetes in women with GDM.

  18 months (+/- 2 months) after delivery

• Adiponectin level

  18 months (+/- 2 months) after delivery

Study Arms (1)

Gestational diabete

EXPERIMENTAL

Other: Blood sampling and OGTT

Interventions

Blood sampling and OGTT OTHER

Gestational diabete

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (7)

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

Bron, 69677, France

Location

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

Clermont-Ferrand, 63003, France

Location

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

Givors, 69700, France

Location

CHU Grenoble - Clinique d'Endocrinologie Diabétologie Nutrition

Grenoble, 38000, France

Location

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

Pierre-Bénite, 69495, France

Location

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

Saint-Etienne, 42055, France

Location

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

Vénissieux, 69200, France

Location

Related Publications (1)

• 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.

  PMID: 25890778 RESULT

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Specimen Collection; Glucose Tolerance Test

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: May 8, 2014
• Study Start: June 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (7)