Gestational Diabetes: a Cohort Study

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03307486
• Other study ID #: 48868915.9.0000.0068
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 25, 2017
• Last updated: October 11, 2017
• Start date: September 17, 2015
• Est. completion date: December 2030

Study information

• Verified date: July 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1400
• Est. completion date: December 2030
• Est. primary completion date: June 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• loss to follow up during pregnancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus in Pregnancy
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy in Diabetics

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 years
Secondary	Need of insulin	To evaluate clinical and laboratory factors as tools to predict the need of insulin during pregnancy	during pregnancy
Secondary	Weight at birth	To evaluate clinical, ultrasonographic and laboratory factors as tools to predict weight at birth (grams)	during pregnancy and delivery
Secondary	Route of delivery	To evaluate clinical, ultrasonographic and laboratory factors as tools to predict the route of delivery	during pregnancy and delivery
Secondary	Neonatal Hypoglycemia	To evaluate clinical, ultrasonographic and laboratory factors as tools to predict neonatal hypoglycemia	during pregnancy and delivery
Secondary	Obesity in the offspring	To evaluate clinical, ultrasonographic and laboratory factors as tools to predict obesity in the offspring of women with GDM	10 years
Secondary	Hypertension in the offspring	To evaluate clinical, ultrasonographic and laboratory factors as tools to predict hypertension in the offspring of women with GDM	10 years
Secondary	Body composition	To assess the body composition of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum	during pregnancy, 6 months postpartum and one year after delivery
Secondary	Physical activity	identify the level of daily physical activity of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum	during pregnancy , 6 months postpartum and 1 year after delivery
Secondary	Eating habits	to verify the eating habits of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum	during pregnancy, 6 months postpartum and 1 year after delivery
Secondary	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	during pregnancy, 6 months postpartum and 1 year after delivery
Secondary	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)	during pregnancy and delivery
Secondary	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)	during pregnancy and delivery
Secondary	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)	during pregnancy and delivery
Secondary	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)	during pregnancy and delivery