Abnormal Post-partum Glucose Metabolism After Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation

NCT01839448 | Completed

• 2 other identifiers: AOI/2012/VC-012013-A00277-38
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

Brief Summary

The main objective of the study is to estimate and compare the percentage of patients with abnormal glucose metabolism at 4-12 weeks postpartum between two groups: patients diagnosed with gestational diabetes before or after 24 weeks of pregnancy. Abnormal glucose metabolism is defined as type 2 diabetes, glucose intolerance or impaired fasting glucose.

Conditions

Gestational Diabetes; Type 2 Diabetes; Glucose Intolerance

Keywords

post partum diabetes; impaired fasting glucose

Outcome Measures

Primary Outcomes (1)

• Presence/absence of abnormal glucose metabolism

  Includes type 2 diabetes, glucose intolerance and impaired fasting glucose

  4 to12 weeks post-partum

Secondary Outcomes (15)

• Presence/absence of type 2 diabetes

  4 to 12 weeks post partum

• Presence/absence of glucose intolerance

  4 to 12 weeks post-partum

• Presence/absence of impaired fasting glucose

  4 to12 weeks post-partum

• Presence/absence of impaired fasting glucose

  4 to12 weeks post-partum

• Patient requiring insulin: yes/no

  4 to12 weeks post-partum

Other Outcomes (3)

• Age

  baseline (day 0)

• Body mass index

  baseline (day 0)

• Number of pregnancies

  baseline (day 0)

Study Arms (2)

GD diagnosis before 24 weeks

Patients in this group are diagnosed with gestational diabetes (GD) before 24 weeks of amenorrhea by means of a fasting blood glucose test \>= 0.92 g/l. Intervention: Post-partum oral glucose tolerance test

Biological: Post-partum oral glucose tolerance test

GD diagnosed at 24 to 28 weeks

Patients in this group are diagnosed with gestational diabetes between 24 and 28 weeks of amenorrhea based on a normal fasting blood glucose level before 24 weeks of amenorrhea AND an abnormal oral glucose tolerance test between 24 and 28 weeks of amenorrhea. Intervention: Post-partum oral glucose tolerance test

Biological: Post-partum oral glucose tolerance test

Interventions

Post-partum oral glucose tolerance test BIOLOGICAL

All patients will have an oral glucose tolerance test at 4 to 12 weeks after the end of pregnancy. Study representatives will contact patients by phone to remind them of the necessity of this test, and its importance for their health.

GD diagnosed at 24 to 28 weeks; GD diagnosis before 24 weeks

Eligibility Criteria

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

Study Population

The study population is composed of pregnant women consulting before 24 weeks of amenorrhea and who have at least one of the following risk factors: age \> 35 years; body mass index \> 25; a family history of type 2 diabetes; a history of gestational diabetes or macrosomia.

You may qualify if:

• The patient must have given her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 10 months of follow-up
• The patient is pregnant and consulting before 24 weeks of amenorrhea AND has at least one of the following risk factors: age \> 35 years; body mass index \> 25; family history of type 2 diabetes; history of gestational diabetes; history of macrosomia.
• The patient has a fasting blood glucose level \>= 0.92 g/l before 24 weeks of amenorrhea OR a fasting blood glucose level \< 0.92 g/l before 24 weeks of amenorrhea AND an abnormal oral glucose tolerance test (75 g of glucose) between 24 and 28 weeks of amenorrhea (normal values are set at T0 \< 0.92 g/l; T60 \< 1.80 g/l; T120 \< 1.53 g/l).

You may not qualify if:

• The patient is participating in another study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient cannot read French
• The patient has a known history of type 2 diabetes
• The patient is diagnosed with type 2 diabetes during pregnancy (fasting blood glucose level \> 1.26 g/l)
• The patient has a contra-indication for a treatment necessary for this study
• The patient is taking chronic or intermittent oral or inhaled corticosteroids, or a β2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (4)

CH d'Arles - Hôpital Joseph Imbert

Arles, 13637, France

Location

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

• Cosma V, Imbernon J, Zagdoun L, Boulot P, Renard E, Brunet C, Mares P, Rodier M, Kabani S, Demattei C, Guedj AM. A prospective cohort study of postpartum glucose metabolic disorders in early versus standard diagnosed gestational diabetes mellitus. Sci Rep. 2021 May 17;11(1):10430. doi: 10.1038/s41598-021-89679-2.

  PMID: 34001938 RESULT

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2; Glucose Intolerance

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; Hyperglycemia

Study Officials

• Valéria Cosma, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Anne-Marie Guedj, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 24, 2013
• Study Start: March 27, 2014
• Primary Completion: October 12, 2016
• Study Completion: October 12, 2016
• Last Updated: November 19, 2025

Record last verified: 2018-01

Locations

FR (4)