Foster City, California 94044

  • Risk Reduction

Purpose:

The objective of the Gestational Diabetes Genetic Socioeconomic Risk Study is to generate genome wide association study data (GWAS) to calculate polygenic risk scores (PRS) for the development of gestational diabetes in pregnant women. Oshun Medical's GWAS study will be conducted by collecting DNA samples alongside medical and socioeconomic data and applying data science methodology to generate a polygenic risk score algorithm for gestational diabetes. Our hypothesis is that key genetic variants linked to gestational diabetes will be identified, and sociodemographic characteristics may impact epigenetic factors which further contribute to this risk of gestational diabetes. The PRS generated through our study will be combined with an analysis of epigenetic factors to produce a new method for predicting risk of developing gestational diabetes during pregnancy.


Study summary:

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.


Criteria:

Inclusion Criteria: - Adult females who are currently pregnant - Adult females who have been pregnant within the last 12 months - Adult female who is currently diagnosed with gestational diabetes - Adult female who has been diagnosed with gestational diabetes within the last 12 months Exclusion Criteria: - Males - Minors/ Children


NCT ID:

NCT04789473


Primary Contact:

Principal Investigator
Barbara Levy, MD
Oshun Medical

Stevie Cline, LLM
Phone: 6148008477
Email: stevie@oshunmedical.com


Backup Contact:

Email: sarah@oshunmedical.com
Sarah Brozio, PhD
Phone: 6693429253


Location Contact:

Foster City, California 94044
United States

Sarah Brozio, PhD
Phone: 669-342-9253
Email: sarah@oshunmedical.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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