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Oral Glucose Tolerance Test and Post Partum Diagnosis of Diabetes Mellitus, Type 2 (DT2 Post-Partum)

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ClinicalTrials.gov Identifier: NCT03644004
Recruitment Status : Not yet recruiting
First Posted : August 23, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Diabetes mellitus, type 2, is a chronic disease which can be linked with many complications in connexion with impaired blood glucose balance.

It diagnosis in risky subjects such as in patients with medical history of gestational diabetes is therefore imperative to prevent its complications.

Actual guidelines recommend an oral tolerance glucose test, measuring glucose levels after oral glucose intake (75g), between 6 an 12 weeks after childbirth. But studies reveal a low diagnosis rate.

The study of the current practices of diagnosis methods seem to be essential in order to improve this diagnosis.


Condition or disease Intervention/treatment
Gestational Diabetes Other: frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Descriptive Study of the Diabetes Mellitus, Type 2 Diagnosis Methods During Postpartum Period in Patients With Medical History of Gestational Diabetes Whom Benefited an Educational Therapy Session.
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Group/Cohort Intervention/treatment
Women with medical history of gestational diabetes
Patients followed at the hospital of Vienne for gestational diabetes in 2016.
Other: frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.

Patients will be contacted by mail with sending of the information notice to ask them to participate in the study.

If they don't reply, the subjects will be called by phone by the investigator to collect their non opposition of participation at the study.

During this call, the investigator will be able to answer all the questions about the study.

The report of this telephone conversation will be register in the medical file of the patient.

Then, we will collect informatic data from the hospital concerning the patients.

After that they will be contacted by phone to answer a survey. Beside, another secure survey will be send by email to each patient's family doctor.

To finish, crossing data between those of the patients and the family doctor and anonymisation of the data.

Other Name: Evaluate the frequency of diabetes mellitus, type 2, diagnosis with an oral glucose tolerance test between 6 and 12 weeks after childbirth in patients with medical history of gestational diabetes.




Primary Outcome Measures :
  1. Performing oral glucose tolerance test in order to detect type 2 diabetes [ Time Frame: Month 6 ]
    Performing oral glucose tolerance test between 6 and 12 weeks after childbirth. As recommended by actual World Health Organisation (WHO) guidelines



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who develop a gestational diabetes.
Criteria

Inclusion Criteria:

  • Patients followed in endocrinology at the hospital of Vienne for gestational diabetes, whom benefited an educational therapy session between the 01/01/2016 and the 31/12/2016 inclusive.

Exclusion Criteria:

  • Minor patients or under legal protection (guardianship)
  • Patients who not speak french
  • Patients who did not declared an attending physician
  • Refusal to take part in the survey
  • Patients lost to follow-up before childbirth
  • Patients whose pregnancy ended by foetal death.
  • Pre-existing diabet before pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644004


Contacts
Contact: Laura BOGENMANN, MD 04.74.31.66.82 ext +33 l.bogenmann@ch-vienne.fr
Contact: Arthur PETILLOT 06.37.11.31.21 ext +33 arthur.petillot@etu.univ-lyon1.fr

Locations
France
Centre hospitalier Lucien Hussel Not yet recruiting
Vienne, France
Contact: Arthur PETILLOT    06.37.11.31.21 ext +33    arthur.petillot@etu.univ-lyon1.fr   
Contact: Sophie MISSOL    06.46.10.41.49 ext +33    sophie.missol@etu.univ-lyon1.fr   
Principal Investigator: Laura BOGENMANN, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Study Director: Laura BOGENMANN, MD Centre Hospitalier de Vienne

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03644004     History of Changes
Other Study ID Numbers: 69HCL18_0210
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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