Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04789473 |
| Other study ID # |
PRE001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 24, 2021 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
June 2021 |
| Source |
Prenome |
| Contact |
Sarah Brozio, PHD |
| Phone |
6693429253 |
| Email |
sarah[@]prenome.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
