Recruiting

Observational Study

Sponsor:

Prenome

Code:

NCT04789473

Conditions

Gestational Diabetes

Pregnancy Complications

Pregnancy Related

Genetic Predisposition

Risk Reduction

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Polygenic Risk Score Generation

Study Details

Brief summary:

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.

Conditions

Gestational Diabetes

Pregnancy Complications

Pregnancy Related

Genetic Predisposition

Risk Reduction

Study ID

NCT04789473

Start date

Jun 24, 2021

Status verified date

Jun, 2021

Completion date

Aug 1, 2022

Anticipated

Primary completion date

Apr 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Gestational Diabetic Cohort

Cohort of adults who are currently pregnant or have been pregnant within the last year, but were diagnosed with gestational diabetes.

Interventions

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.

Primary outcome measure

  • Polygenic Risk Score Prediction for Gestational Diabetes [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Sarah Brozio, PHD

6693429253sarah@prenome.com

Stevie Cline, LLM

6148008477stevie@prenome.com

Locations

Illumina Accelerator

Recruiting

Foster City, California, United States, 94044

Contacts

Sarah Brozio, PhD

669-342-9253sarah@prenome.com

Stevie Cline, LLM

6148008477clinical@prenome.com

Principal Investigator:

Barbara Levy, MD

More Information

Sponsor

Prenome

Last update posted

Jun 30, 2021

Last verified

Jun, 2021

Keywords

  • Gestational Diabetes
  • Polygenic Risk Score
  • Genomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Prenome on 2021-06-30.