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

Type 2 Diabetes Clinical Trial

— DG Post-Partum  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839448
• Other study ID #: AOI/2012/VC-01
• Secondary ID: 2013-A00277-38
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: January 2, 2018
• Start date: March 27, 2014
• Est. completion date: August 16, 2017

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ß2 agonist treatment for a previous disease or a disease discovered during pregnancy within one week preceding the fasting glucose or oral glucose tolerance test.

Related Conditions & MeSH terms

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

Intervention

Biological:
• Post-partum oral glucose tolerance test
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.

Locations

Country	Name	City	State
France	CH d'Arles - Hôpital Joseph Imbert	Arles Cedex
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier Cedex 5
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age		baseline (day 0)
Other	Body mass index		baseline (day 0)
Other	Number of pregnancies		baseline (day 0)
Primary	Presence/absence of abnormal glucose metabolism	Includes type 2 diabetes, glucose intolerance and impaired fasting glucose	4 to12 weeks post-partum
Secondary	Presence/absence of type 2 diabetes		4 to 12 weeks post partum
Secondary	Presence/absence of glucose intolerance		4 to 12 weeks post-partum
Secondary	Presence/absence of impaired fasting glucose	American definition: defined as between 1 and 1.26 g/l	4 to12 weeks post-partum
Secondary	Presence/absence of impaired fasting glucose	European definition: defined as between 1.1 and 1.26 g/l	4 to12 weeks post-partum
Secondary	Patient requiring insulin: yes/no		4 to12 weeks post-partum
Secondary	Presence/absence of complications	This includes a yes/no response for each of the following: caesarean section, hypertension, preeclampsia, urinary tract infection, macrosomia, dystocia, neonatal transfer, respiratory distress, threat of premature birth.	4 to12 weeks post-partum
Secondary	Baby's weight at birth (kg)		4 to 12 weeks post-partum
Secondary	Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age)		4 to 12 weeks post-partum
Secondary	Patient was older than 35 years of age at beginning of pregnancy? yes/no		baseline (day 0)
Secondary	Body mass index > 25 at beginning of pregnancy? yes/no		baseline (day 0)
Secondary	First degree family history of type 2 diabetes? yes/no		baseline (day 0)
Secondary	History of gestational diabetes? yes/no		baseline (day 0)
Secondary	History of macrosomia? yes/no		baseline (day 0)
Secondary	Fasting glucose (g/l)		before 24 weeks of amenorrhea
Secondary	Oral glucose tolerance test results if necessary		24 to 28 weeks of amenorrhea