OneinSeven Gestational Diabetes Genetic and Socioeconomic Risk Study

Gestational Diabetes Genetic and Socioeconomic Risk Study OneinSeven Gestational Diabetes Genetic and Socioeconomic Risk Study

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 Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Pregnancy Related; Gestational Diabetes; Risk Reduction; Genetic Predisposition
• Intervention / Treatment: Genetic: Polygenic Risk Score Generation

Detailed 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 diagnosed 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.

Very few genome-wide association studies have been carried out to correlate genetic variants to gestational diabetes, and have identified a small non-exhaustive number of genes linked to the condition. The list comprises genes encoding transcription factors such as TCF7L2 and genes required for glucose processing such as GCK and GCKR. Many of these genes are also associated with the risk of Type II diabetes. A large number of GWAS have identified genes tightly associated with Type II diabetes including CDKALI 1, FOXO1, GCKR and FTO, and the risk of gestational diabetes and type II is strongly correlated. 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 different types of diabetes including gestational diabetes . However, there are currently no PRS for gestational diabetes 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 and often focus on specific sub-populations. Prenome 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, Prenome's PRS will be more representative of a patient's personal health and risk of developing gestational diabetes.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Sarah Brozio, PHD; Phone Number: 6693429253; Email: sarah@prenome.com
• Study Contact Backup: Name: Stevie Cline, LLM; Phone Number: 6148008477; Email: stevie@prenome.com

Study Locations

• United States
  • California
    • Foster City, California, United States, 94044
      • Recruiting
      • Illumina Accelerator
      • Contact: Sarah Brozio, PhD; Phone Number: 669-342-9253; Email: sarah@prenome.com
      • Contact: Stevie Cline, LLM; Phone Number: 6148008477; Email: clinical@prenome.com
      • Principal Investigator: Barbara Levy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The population included in this study are pregnant or recently pregnant women, with a focus on women who are currently diagnosed or have previously been diagnosed with gestational diabetes. The population are being recruited from all adult age ranges, ethnicities, races and location across the united states.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Normal Glycemic Pregnancy; Cohort of control adults who are currently pregnant or have been pregnant within the last year, but were not diagnosed with gestational diabetes.	Genetic: Polygenic Risk Score Generation; PRS will be calculated for gestational diabetes risk using both cohorts, participants wont have results returned to them during the study.
Gestational Diabetic Cohort; Cohort of adults who are currently pregnant or have been pregnant within the last year, but were diagnosed with gestational diabetes.	Genetic: Polygenic Risk Score Generation; PRS will be calculated for gestational diabetes risk using both cohorts, participants wont have results returned to them during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polygenic Risk Score Prediction for Gestational Diabetes	A predictive model of genetic risk of developing gestational diabetes based on comparing variants between control and diabetic groups.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Social Determinants of Health on Risk	The impact of a social determinant from survey data on the generated genetic risk assessment.	1 year

Collaborators and Investigators

• Sponsor: Prenome
• Investigators: Principal Investigator: Barbara Levy, MD, Prenome

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Genomics; Gestational Diabetes; Polygenic Risk Score
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Mellitus; Disease Susceptibility; Pregnancy Complications; Diabetes, Gestational; Genetic Predisposition to Disease
• Other Study ID Numbers: PRE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No