OneinSeven Gestational Diabetes Genetic and Socioeconomic Risk Study

NCT04789473 | Unknown DMC

• 1 other identifier: PRE001
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Keywords

Gestational Diabetes; Polygenic Risk Score; Genomics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Impact of Social Determinants of Health on Risk

  1 year

Study Arms (2)

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

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

Interventions

Polygenic Risk Score Generation GENETIC

PRS will be calculated for gestational diabetes risk using both cohorts, participants wont have results returned to them during the study.

Control Normal Glycemic Pregnancy; Gestational Diabetic Cohort

Eligibility Criteria

• Age: 18 Years+
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Males
• Minors/ Children

Sponsors & Collaborators

• Prenome: lead

Study Sites (1)

Illumina Accelerator

Foster City, California, 94044, United States

RECRUITING

Related Links

• Study Sign Up

Biospecimen

Retention: SAMPLES WITH DNA

Saliva specimens used for DNA collection.

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Genetic Predisposition to Disease; Risk Reduction Behavior; Genetic Risk Score

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Barbara Levy, MD

  Prenome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Brozio, PHD

CONTACT

6693429253; sarah@prenome.com

Stevie Cline, LLM

CONTACT

6148008477; stevie@prenome.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 9, 2021
• Study Start: June 24, 2021
• Primary Completion: April 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)