Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Genetic Predisposition
  • Gestational Diabetes
  • Pregnancy Complications
  • Pregnancy Related
  • Risk Reduction
Type
Observational
Design
Observational Model: CohortTime Perspective: Retrospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Gestational diabetes is a condition where high blood glucose levels occur during pregnancy and the mother was not diabetic before pregnancy. Between 6-9% of pregnancies are affected by this disorder. Gestational diabetes is usually tested for with a glucose challenge test where a blood glucose level...

Gestational diabetes is a condition where high blood glucose levels occur during pregnancy and the mother was not diabetic before pregnancy. Between 6-9% of pregnancies are affected by this disorder. Gestational diabetes is usually tested for with a glucose challenge test where a blood glucose level of 190mg/dL or above would be indicative of gestational diabetes. This test usually occurs around 24-28 weeks into pregnancy. If a patient has other risk factors such as obesity or family history of diabetes, the assessment may be performed earlier. Gestational diabetes increases risk of complications in both the mother and the baby. For the child, it may result in excessive weight at birth, a preterm birth, hypoglycemia, Type II diabetes later in life, and potential stillbirth. For the mother, it drastically increases the risk of high blood pressure, preeclampsia, and developing diabetes later in life. Gestational diabetes can also lead to further pregnancy related complications and increased risk of maternal morbidity and mortality events. Multiple genome-wide association studies have been carried out to correlate genetic variants to Type II diabetes, and have identified over 40 genes associated with the disease. The list comprises genes encoding for insulin production and processing such as CDKALI 1, FOXO1, GCKR and FTO, and insulin pathway genes such as MADD and PRC1[2]. These variants, along with demonstrated non-genetic risk factors such as obesity and high blood pressure, have demonstrated a clear ability to assess risk of Type II diabetes. However, there are currently no PRS for gestational diabetes in academic literature or available as a market product in any country. Additionally, the studies mentioned above do not wholly combine genome data with sociodemographic and lifestyle risks. Very few large scale GWAS studies have focused solely on female participants or pregnancy related complications. Further, existing literature and publications lack diversity among female participants in these types of studies. Oshun Medical intends to conduct a large-scale GWAS in conjunction with the additional socioeconomic qualifications to generate a novel PRS to assess the risk of gestational diabetes with focus on inclusion of diverse populations in our samples. With these added quantifications of qualitative data, Oshun Medical's PRS will be more representative of a patient's personal health and risk of developing gestational diabetes.

Tracking Information

NCT #
NCT04789473
Collaborators
Not Provided
Investigators
Principal Investigator: Barbara Levy, MD Oshun Medical