Gestational Diabetes: a Cohort Study

NCT03307486 | Enrolling By Invitation

• 1 other identifier: 48868915.9.0000.0068
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes; Diabetes, Gestational; Diabetes Mellitus in Pregnancy; Diabetes Mellitus, Type 2

Keywords

Gestational diabetes; Type 2 DM after GDM

Outcome Measures

Primary Outcomes (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

  10 years

Secondary Outcomes (14)

• Need of insulin

  during pregnancy

• Weight at birth

  during pregnancy and delivery

• Route of delivery

  during pregnancy and delivery

• Neonatal Hypoglycemia

  during pregnancy and delivery

• Obesity in the offspring

  10 years

Study Arms (1)

Gestational diabetes

Women diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• loss to follow up during pregnancy

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

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

São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: October 11, 2017
• Study Start: September 17, 2015
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 12, 2017

Record last verified: 2017-07

Locations

BR (1)