Gestational DiabetesNCT03644004
Oral Glucose Tolerance Test and Post Partum Diagnosis of Diabetes Mellitus, Type 2 (DT2 Post-Partum)
An observational study of Gestational Diabetes, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.
- Type of treatment
- Pill or oral medicine
- How many people
- 173 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2018to 13 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who develop a gestational diabetes.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Gestational Diabetes
- Being tested
- frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.Other
Also called 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Women with medical history of gestational diabetes | Patients followed at the hospital of Vienne for gestational diabetes in 2016. Receives: Other: frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performing oral glucose tolerance test in order to detect type 2 diabetes
Performing oral glucose tolerance test between 6 and 12 weeks after childbirth. As recommended by actual World Health Organisation (WHO) guidelines
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start30 Oct 2018
- Primary completion13 Feb 2019
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura BOGENMANN, MD, Study director, Centre Hospitalier de Vienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644004
- Sponsor's protocol ID
- 69HCL18_0210
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03644004
- Acronym / sponsor ID
- 69HCL18_0210
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with medical history of gestational diabetes | – | Other: frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.Patients followed at the hospital of Vienne for gestational diabetes in 2016. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who develop a gestational diabetes.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.Also: 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.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 | Women with medical history of gestational diabetes |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura BOGENMANN, MD study director
Centre Hospitalier de Vienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performing oral glucose tolerance test in order to detect type 2 diabetes (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.