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Gestational DiabetesNCT03307486

Gestational Diabetes: a Cohort Study

An observational study of Gestational Diabetes and Diabetes, Gestational, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its occurrence implies an increased risk of maternal and fetal complications and, therefore, its diagnosis and treatment are extremely important. Read more about this study

Who is it for?
Any age, women only
Type of treatment
Pill or oral medicine
How many people
1,400 participants
Where
1 siteBrazil
Study dates
17 Sep 2015to Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients who were diagnosed with gestational diabetes after the adoption of the diagnostic criteria proposed by the IADPSG (June 2011) will be evaluated retrospectively and prospectively in the high-risk prenatal outpatient clinic of the Obstetric Clinic of the Hospital das Clínicas of the Medical School of the University of São Paulo (HCFMUSP), a tertiary teaching hospital in Sao Paulo, Brazil.

Who may be able to join

  • single pregnancies
  • absence of glucose intolerance prior to gestation (defined by prior diagnosis of polycystic ovarian syndrome or fasting glycemia ≥100mg / dl or 2hr post-overload with 75g glucose ≥ 140mg / dL or glycated hemoglobin ≥ 5.7% previously to pregnancy)
  • absence of chronic use of glucocorticoids or antiretroviral drugs for HIV virus, given its diabetogenic effect and potential confounding
  • diagnosis of GDM according to diagnostic criteria proposed by the IADPSG, namely: initial fasting blood glucose ≥ 92mg / dL OR oral glucose tolerance test of 75g with fasting ≥ 92mg / dL or after1h ≥ 180mg / dL or after 2h ≥ 153mg / dL
  • Agreement with the informed consent term for patients who will be followed prospectively
  • Agreement with the free and informed consent term for recall and reassessment of the patients identified in the retrospective analysis of the data

Who cannot join

  • loss to follow up during pregnancy

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 05403000

Other trials in Brazil

About this study

Official title: Fetal and Maternal Repercussions of Gestational Diabetes After the Adoption of the Diagnostic Criteria Proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG): a Cohort Study

Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its occurrence implies an increased risk of maternal and fetal complications and, therefore, its diagnosis and treatment are extremely important. Since the adoption of the new diagnostic criteria proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up and treatment. The need and benefit of treatment in these cases of mild hyperglycemia has been discussed worldwide. Women who have been diagnosed with GDM are at increased risk for type 2 DM in the years following gestation. Other factors (such as lipid profile, obesity, adipokine dosage) may also be related to the repercussions of GDM on the maternal-fetal binomial, since gestations with satisfactory glycemic control can also present complications related to the disease and increased risk of type 2 DM in the long term. The present study aims to investigate factors associated with the need for insulin use, the occurrence of perinatal complications, nutritional status, physical activity and weight retention one year after delivery and the postpartum diagnosis of type 2 DM 10 years after delivery in women diagnosed with GDM according to the current criteria suggested by the IADPSG.

Keywords
Gestational diabetes, Type 2 DM after GDM
Medical subject headings
Diabetes, Gestational, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03307486
Study groupRoleWhat they receive
Gestational diabetesWomen diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of type 2 DM after GDM

    To evaluate clinical, nutritional and laboratory factors as tools to predict the diagnosis of type 2 DM, carbohydrate intolerance or postpartum metabolic syndrome in women who had GDM

    Measured: 10 years

Secondary outcomes (14)

  1. Need of insulin

    To evaluate clinical and laboratory factors as tools to predict the need of insulin during pregnancy

    Measured: during pregnancy

  2. Weight at birth

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict weight at birth (grams)

    Measured: during pregnancy and delivery

  3. Route of delivery

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict the route of delivery

    Measured: during pregnancy and delivery

  4. Neonatal Hypoglycemia

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict neonatal hypoglycemia

    Measured: during pregnancy and delivery

  5. Obesity in the offspring

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict obesity in the offspring of women with GDM

    Measured: 10 years

  6. Hypertension in the offspring

    To evaluate clinical, ultrasonographic and laboratory factors as tools to predict hypertension in the offspring of women with GDM

    Measured: 10 years

  7. Body composition

    To assess the body composition of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum

    Measured: during pregnancy, 6 months postpartum and one year after delivery

  8. Physical activity

    identify the level of daily physical activity of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum

    Measured: during pregnancy , 6 months postpartum and 1 year after delivery

  9. Eating habits

    to verify the eating habits of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum

    Measured: during pregnancy, 6 months postpartum and 1 year after delivery

  10. Weight retention

    To study association between levels of physical activity and dietary intake and the weight retention in women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum

    Measured: during pregnancy, 6 months postpartum and 1 year after delivery

  11. Route of delivery vs physical activity

    to study association between the level of physical activity in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)

    Measured: during pregnancy and delivery

  12. Route of delivery vs eating habits

    to study association between the eating habits in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)

    Measured: during pregnancy and delivery

  13. Fetal weight at birth vs physical activity

    to study association between physical activity in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)

    Measured: during pregnancy and delivery

  14. Fetal weight at birth vs eating habits

    to study association between eating habits in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)

    Measured: during pregnancy and delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2017
  2. Study start17 Sep 2015
  3. Primary completionJun 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
Prospective
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03307486
Sponsor's protocol ID
48868915.9.0000.0068
Status last verified
Jul 2017
First submitted
25 Jul 2017
Last updated
12 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gestational Diabetes and Diabetes, Gestational, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 6 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 12 Oct 2017. 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 Brazil. 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?

This study is still under way. Results are not available in the source record yet.

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?

Occurrence of type 2 DM after GDM (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03307486.

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 12 Oct 2017.

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