Clinical trial NCT01839448: Abnormal Post-partum Glucose Metabolism After Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation
Official title: Frequency of Abnormal Glucose Metabolism (Diabetes, Impaired Glucose Tolerance, Impaired Fasting Glucose) in the Immediate Postpartum Period Following Gestational Diabetes Diagnosed Before or After 24 Weeks of Gestation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Type 2 Diabetes
Glucose Intolerance
Keywords: post partum diabetes
impaired fasting glucose
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-04-24
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The secondary objectives of this study are to compare between the two groups:

A. the rate of type 2 diabetes only, glucose intolerance only, impaired fasting glucose only, and patients requiring insulin at 4-12 weeks postpartum

B. rates of maternal and obstetric complications

C. risk factors (age, body mass index, personal history of gestational diabetes or macrosomia, first degree family history of diabetes).

D. For fasting glucose done before 24SA, we will calculate the optimal threshold for predicting abnormal glucose metabolism in the immediate postpartum period among women with gestational diabetes.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study, with the exception of the following studies: Papillo PMA (RCB 2013-A00538-37), LXRs (RCB 2009-A00968-49), GrossPath (RCB 2014-A01120-47), BAKRI (RCB 2013-A00914-41), OASIS II (RCB 2013-A00773-42), ElastoMAP (RCB 2013-A01148-37), ElastoDéclench (RCB 2014-A00828-39) and UpSideDown (RCB 2014-A01921-46).
* 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.

Primary outcomes:
measure: Presence/absence of abnormal glucose metabolism
timeFrame: 4 to12 weeks post-partum
Secondary outcomes:
measure: Presence/absence of type 2 diabetes
timeFrame: 4 to 12 weeks post partum
measure: Presence/absence of glucose intolerance
timeFrame: 4 to 12 weeks post-partum
measure: Presence/absence of impaired fasting glucose
timeFrame: 4 to12 weeks post-partum
measure: Presence/absence of impaired fasting glucose
timeFrame: 4 to12 weeks post-partum
measure: Patient requiring insulin: yes/no
timeFrame: 4 to12 weeks post-partum
measure: Presence/absence of complications
timeFrame: 4 to12 weeks post-partum
measure: Baby's weight at birth (kg)
timeFrame: 4 to 12 weeks post-partum
measure: Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age)
timeFrame: 4 to 12 weeks post-partum
measure: Patient was older than 35 years of age at beginning of pregnancy? yes/no
timeFrame: baseline (day 0)
measure: Body mass index > 25 at beginning of pregnancy? yes/no
timeFrame: baseline (day 0)
measure: First degree family history of type 2 diabetes? yes/no
timeFrame: baseline (day 0)
measure: History of gestational diabetes? yes/no
timeFrame: baseline (day 0)
measure: History of macrosomia? yes/no
timeFrame: baseline (day 0)
measure: Fasting glucose (g/l)
timeFrame: before 24 weeks of amenorrhea
measure: Oral glucose tolerance test results if necessary
timeFrame: 24 to 28 weeks of amenorrhea
Other outcomes:
measure: Age
timeFrame: baseline (day 0)
measure: Body mass index
timeFrame: baseline (day 0)
measure: Number of pregnancies
timeFrame: baseline (day 0)
Locations:
city: Arles Cedex
country: France
facility: CH d'Arles - Hôpital Joseph Imbert
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Valéria Cosma, MD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Anne-Marie Guedj, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.