Gestational DiabetesNCT04789473
OneinSeven Gestational Diabetes Genetic and Socioeconomic Risk Study
An observational study of Gestational Diabetes and Pregnancy Complications, run by Prenome at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Pregnancy Complications, Pregnancy Related
- What is being tested?
- Polygenic Risk Score Generation
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Males
- Minors/ Children
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Illumina Accelerator
Foster City, California, 94044
Sarah Brozio, PhD, 669-342-9253, sarah@prenome.com
Stevie Cline, LLM, 6148008477, clinical@prenome.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestational Diabetes, Pregnancy Complications, Pregnancy Related, Genetic Predisposition, Risk Reduction
- Being tested
- Polygenic Risk Score Generation
- Keywords
- Gestational Diabetes, Polygenic Risk Score, Genomics
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications, Genetic Predisposition to Disease, Risk Reduction Behavior, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygenic Risk Score GenerationGenetic
PRS will be calculated for gestational diabetes risk using both cohorts, participants wont have results returned to them during the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Genetic: Polygenic Risk Score Generation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Impact of Social Determinants of Health on Risk
The impact of a social determinant from survey data on the generated genetic risk assessment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start24 Jun 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prenome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Levy, MD, Principal investigator, Prenome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789473
- Sponsor's protocol ID
- PRE001
- Status last verified
- Jun 2021
- First submitted
- 3 Mar 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Diabetes Genetic and Socioeconomic Risk Study OneinSeven Gestational Diabetes Genetic and Socioeconomic Risk Study
- ClinicalTrials.gov ID
- NCT04789473
- Acronym / sponsor ID
- PRE001
- Conditions
- Gestational Diabetes, Pregnancy Complications, Pregnancy Related, Genetic Predisposition, Risk Reduction
- Keywords
- Gestational Diabetes, Polygenic Risk Score, Genomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- PrenomeIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Normal Glycemic Pregnancy | – | Genetic: Polygenic Risk Score GenerationCohort 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 | – | Genetic: Polygenic Risk Score GenerationCohort of adults who are currently pregnant or have been pregnant within the last year, but were diagnosed with gestational diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Males
- Minors/ Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygenic Risk Score GenerationPRS will be calculated for gestational diabetes risk using both cohorts, participants wont have results returned to them during the study. | Genetic | Control Normal Glycemic Pregnancy, Gestational Diabetic Cohort |
Primary outcome
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.
1 secondary outcome
Impact of Social Determinants of Health on Risk
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Study Sign UpLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Levy, MD principal investigator
Prenome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Pregnancy Complications, run by Prenome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Brozio, PHD (6693429253, sarah@prenome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polygenic Risk Score Prediction for Gestational Diabetes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.