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

This study is currently recruiting participants.
Verified April 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01839448
First received: April 22, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Gestational Diabetes
Type 2 Diabetes
Glucose Intolerance
Biological: Post-partum oral glucose tolerance test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence/absence of abnormal glucose metabolism [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
    Includes type 2 diabetes, glucose intolerance and impaired fasting glucose


Secondary Outcome Measures:
  • Presence/absence of type 2 diabetes [ Time Frame: 4 to 12 weeks post partum ] [ Designated as safety issue: No ]
  • Presence/absence of glucose intolerance [ Time Frame: 4 to 12 weeks post-partum ] [ Designated as safety issue: No ]
  • Presence/absence of impaired fasting glucose [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
    American definition: defined as between 1 and 1.26 g/l

  • Presence/absence of impaired fasting glucose [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
    European definition: defined as between 1.1 and 1.26 g/l

  • Patient requiring insulin: yes/no [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
  • Presence/absence of complications [ Time Frame: 4 to12 weeks post-partum ] [ Designated as safety issue: No ]
    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.

  • Baby's weight at birth (kg) [ Time Frame: 4 to 12 weeks post-partum ] [ Designated as safety issue: No ]
  • Weeks of amenorrhea (duration of pregnancy in weeks/ gestational age) [ Time Frame: 4 to 12 weeks post-partum ] [ Designated as safety issue: No ]
  • Patient was older than 35 years of age at beginning of pregnancy? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Body mass index > 25 at beginning of pregnancy? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • First degree family history of type 2 diabetes? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • History of gestational diabetes? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • History of macrosomia? yes/no [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Fasting glucose (g/l) [ Time Frame: before 24 weeks of amenorrhea ] [ Designated as safety issue: No ]
  • Oral glucose tolerance test results if necessary [ Time Frame: 24 to 28 weeks of amenorrhea ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Age [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Number of pregnancies [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

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
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839448

Contacts
Contact: Anne-Marie Guedj, MD +33.(0)4.66.68.33.21 anne.marie.guedj@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU de Montpellier - Hôpital Lapeyronie Recruiting
Montpellier, France, 34295
Sub-Investigator: Cécile Brunet, MD         
Sub-Investigator: Eric Renard, MD, PhD         
CHU de Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier Cedex 5, France, 34295
Sub-Investigator: Pierre Boulot, MD, PhD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Sub-Investigator: Valéria Cosma, MD         
Principal Investigator: Anne-Marie Guedj, MD         
Sub-Investigator: Michel Rodier, MD         
Sub-Investigator: Pierre Marès, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Valéria Cosma, MD Centre Hospitalier Universitaire de Nîmes
Principal Investigator: Anne-Marie Guedj, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01839448     History of Changes
Other Study ID Numbers: AOI/2012/VC-01, 2013-A00277-38
Study First Received: April 22, 2013
Last Updated: April 4, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
post partum diabetes
impaired fasting glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes, Gestational
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Hyperglycemia

ClinicalTrials.gov processed this record on April 16, 2014