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OneinSeven Gestational Diabetes Genetic and Socioeconomic Risk Study

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ClinicalTrials.gov Identifier: NCT04789473
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
Prenome

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.

Condition or disease Intervention/treatment
Gestational Diabetes Pregnancy Complications Pregnancy Related Genetic Predisposition Risk Reduction 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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Gestational Diabetes Genetic and Socioeconomic Risk Study OneinSeven Gestational Diabetes Genetic and Socioeconomic Risk Study
Actual Study Start Date : June 24, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


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.




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


Secondary Outcome Measures :
  1. Impact of Social Determinants of Health on Risk [ Time Frame: 1 year ]
    The impact of a social determinant from survey data on the generated genetic risk assessment.


Biospecimen Retention:   Samples With DNA
Saliva specimens used for DNA collection.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789473


Contacts
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Contact: Sarah Brozio, PHD 6693429253 sarah@prenome.com
Contact: Stevie Cline, LLM 6148008477 stevie@prenome.com

Locations
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United States, California
Illumina Accelerator Recruiting
Foster City, California, United States, 94044
Contact: Sarah Brozio, PhD    669-342-9253    sarah@prenome.com   
Contact: Stevie Cline, LLM    6148008477    clinical@prenome.com   
Principal Investigator: Barbara Levy, MD         
Sponsors and Collaborators
Prenome
Investigators
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Principal Investigator: Barbara Levy, MD Prenome
  Study Documents (Full-Text)

Documents provided by Prenome:
Study Protocol  [PDF] May 5, 2021

Additional Information:
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Responsible Party: Prenome
ClinicalTrials.gov Identifier: NCT04789473    
Other Study ID Numbers: PRE001
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: June 30, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prenome:
Gestational Diabetes
Polygenic Risk Score
Genomics
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Disease Susceptibility
Genetic Predisposition to Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes