Gestational Diabetes Genetic and Socioeconomic Risk Study OneinSeven Gestational Diabetes Genetic and Socioeconomic Risk Study
Conditions: Gestational Diabetes, Pregnancy Complications, Pregnancy Related, Genetic Predisposition, Risk Reduction
Sponsor: Prenome

Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
GESTATIONAL DIABETES GENETIC AND
SOCIOECONOMIC RISK PROTOCOL
VERSION DATE: 05/05/2021
STUDY SUMMARY
Investigational Agent(s)
(Drugs or Devices)
N/A
IND / IDE / HDE #
No
Special Population(s)
Pregnant Women
Sample Size
10,000 Participants
Funding Source
Prenome (Industry)
Indicate the type of consent
to be obtained
Electronic Consent
Written Consent
Site
500 Lincoln Centre Drive, Foster City, CA 94404
Research Related Radiation
Exposure
Yes
No ✔️
DSMB / DMC / IDMC
Yes ✔️
No
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
OBJECTIVES
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.
Prenome’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.
BACKGROUND
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[1].
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
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
such as GCK and GCKR[2]. 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[3]. 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 ENDPOINTS
The end point of this study is the generation of a polygenic risk score for gestational
diabetes
from
whole
genome
sequencing
of
10,000
DNA
samples
and
sociodemographic data from currently pregnant or recently (< 1 year since birth)
pregnant participants.
STUDY INTERVENTION
This study does not require any intervention procedures. Participants will be
recruited for saliva samples for DNA isolation and data collection only.
PROCEDURES INVOLVED
In order to generate a polygenic risk score for gestational diabetes, Prenome will
conduct
a GWAS by gathering DNA samples and information from 10,000
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
participants who satisfy one of the following qualifications: women who are
currently > 24 weeks pregnant, women who have been pregnant within the last
year, women with or without a history of gestational diabetes, and women who
currently have gestational diabetes.
Participants
will
be
recruited
through
OB/GYN
clinics,
patient
recruitment
organizations or directly by Prenome through an established waitlist and an online
advertising campaign. Interested persons will receive materials fully explaining the
study and consent processes in detail through a series of pre-prepared email
templates. This will include a video, a detailed description in the consent form, and
information displayed on the company or study websites (www.prenome.com or
www.gestationaldiabetesstudy.com ). All interested persons will have the option to
consult Prenome staff about this study by contacting the clinical@prenome.com
email. This information will be presented online and in communication emails.
Prenome will be accessing participant’s personal information through medical
records to collect information on impactful risk factors and pregnancy outcome
data. Samples will be collected from two participant cohorts: a control group
containing 5000 participants with normoglycemic pregnancies and a second group
containing 5000 diagnosed with gestational diabetes.
Registered participants may request collection kits to be sent directly to a desired
address (personal or clinical recruitment site) and may consent to participate
electronically; this is to address safety concerns due to COVID-19. Once recruited
into the study, participants will be mailed a DNA sample collection kit (provided by
Prenome) containing either an Oragene OGD-510 or OCD-100 saliva tube or Zymo
R1210-E saliva tube. These sample collection devices have received FDA 510(k)
clearance, and contain chemistry which lyses enveloped viruses such as SARS-CoV2,
ensuring subject safety. Participants will register the identifier barcode on the
collection device, which will be used to link medical data to their sample. The
participant will spit directly into the saliva collection tube for DNA sample
collection,
and
subjects
will
be
asked
to
complete
a
questionnaire
about
socioeconomic demographics and medical history. Access to this questionnaire will
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
be
granted
online
at
the
point
of
sample
collection
kit
registration.
This
questionnaire will take no more than 30 minutes to complete.
Regardless of the recruitment site, samples will be returned to the Prenome study
lead site for processing, DNA sequencing, and data analysis. Research scientists
handling participant samples will have access to the unique identifier number on
the collection device ONLY. This is to ensure participant privacy and protection of
PHI, while also allowing processing to remain blind to participants’ diabetic status.
The samples will undergo DNA isolation and library preparation following the
DNA/RNA Prep Work Flow with Exome Enrichment using Illumina preparation
chemistry. Whole genome and whole exome sequencing will be carried out,
sequencing all samples to a minimum coverage of 1X. The sequencing data will be
used to identify linkage of associated alleles and variants that determine risk of
gestational diabetes, and then tied to medical or socioeconomic data which
increases or decreases risk.
This clinical study will result in a novel PRS which can be used to assess risk of
gestational diabetes. Any remaining isolated DNA or saliva will be stored in the
Prenome BioBank using the de-identified barcode assigned at collection.
DATA AND SPECIMEN BANKING
An anonymised participant ID database with assigned storage space will be used to
monitor storage of participant DNA. This database will include information on
anonymised ID, DNA concentration, date isolated, estimated destruction date and
sequencing status. All isolated DNA will be stored at -80°C with duplicates of each
sample held in two separate freezers. DNA samples will be stored for 10 years after
collection and then will be destroyed. Final DNA libraries generated from library
preparation of participant samples will be stored for 6 months after preparation and
sequencing. These samples will also be catalogued by anonymised IDs, along with
quality control data and sequencing status. If participants remove themselves from
the study, all of their samples will be destroyed upon the exit request.
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
As a secondary storage method DNA Genotek Oragene or Zymo saliva collection
allows for long term saliva sample storage at -20°C. Once appropriate sample
volumes have been taken for DNA isolation and library preparation, the remaining
sample will be aliquoted into 1ml cryogenic storage tubes as per DNAGenotek
guidelines. The samples will be stored and catalogued using the ID assigned at kit
registration, and will be stored for 10 years after collection. As with DNA samples, if
participants withdraw from the study and request for their samples to be removed,
they will be thawed and destroyed.
SHARING RESULTS WITH PARTICIPANTS
As this study is collecting samples retrospectively, the polygenic risk scores
calculated in this study will not be returned to participants as their pregnancy
outcomes are already defined. However, the results of this study will be published
to an open access journal, and updates on the study status will be available on the
Prenome Website. No information published will contain personal information or
personal PRS outcomes.
STUDY TIMELINES
The One in Seven Gestational Diabetes Risk Study will be collecting samples from
participants for a 1 year period, with data analysis and PRS calculation continuing
for 1 year after the final sample collection.
INCLUSION AND EXCLUSION CRITERIA
The control cohort will include 5000 adult women who are over 24 weeks pregnant
or have given birth to a child within 1 year, who have not received a diagnosis of
gestational diabetes and were not diabetic during or before their pregnancy. The
diabetic cohort will include 5000 adult women who are over 24 weeks pregnant or
have given birth to a child within 1 year, who received any diagnosis of gestational
diabetes during their pregnancy. There is no adult age, race or ethnicity exclusion
criteria for this study, as our intention is to generate PRS based on diverse
populations in line with percentage diversity of the US population. However, minors
are not eligible to participate in this study. Male participation is excluded from this
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
study. Non-english speakers are excluded from recruitment, this is due to the
consent process being available in English only.
VULNERABLE POPULATIONS
Vulnerable populations include pregnant women, visually impaired participants,
and
women
with
a
history
of
gestational
diabetes.
No
conversations
or
documentation
given
to
participants
will
discuss
pregnancy
termination.
information produced in this study will be returned to participants, and will be not
used to influence decisions related to termination of pregnancy. No inducements,
monetary or otherwise will be offered to influence pregnancy termination. In order
to ensure the safety and comfort of these participants, the collection kit aims to be
as minimally invasive as possible and available to participants in their homes to
reduce Covid-19 exposure in clinical environments. Visually impaired persons will
have access to this study, and the instructions will be available in a verbal format to
increase understanding.
RECRUITMENT METHODS
Participants will be recruited through two channels. The first is through
partnered clinical sites referred to Prenome by healthcare providers, where
participants receive obstetric care. Clinicians at these sites will be able to identify
qualifying participants and register them through the company or study
websites (www.prenome.com or www.gestationaldiabetesstudy.com) which are
connected
to
a
HIPAA
compliant
CRM
portal,
and
initiate
their
study
involvement.
Participants will also be able to directly sign up to this study through a clinical
study
sign
up
form
featured
on
the
Prenome
or
study
websites
(www.prenome.com
or
www.gestationaldiabetesstudy.com).
Any
person
currently over 24 weeks pregnant or previously pregnant within the last year
may register interest in participation on the Prenome website. Prenome will use
a series of standardized email templates to communicate with participants at
every stage of the study including sign up, consent and kit collection. Interested
persons will have access to a video and written materials explaining the study
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
and consent processes in detail. They will then be able to complete the sign-up
and consent process online. Participants may request a consultation with
Prenome to discuss the study if they require more information. Information
about study participation through this route will be advertised online including
social media and pregnancy related blogs. External sites will be given access to
the same advertising materials for recruitment.
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES
All participants will receive a $20 Uber Eats or Amazon gift card, upon delivery of
their saliva sample to the Prenome lead site, for contributing to this research study.
The gift card will be emailed to participants by default, but participants may
request a physical gift card be mailed to them.
WITHDRAWAL OF PARTICIPANTS
Participants may withdraw from the study at any stage of the process. In order to
formally withdraw, participants can request a withdrawal form through the
Prenome contact email (clinical@prenome.com) supplied in their communication
emails, consent form, collection kit or on the Prenome website. Participants can
physically or digitally sign the withdrawal form, and return this to the contact email
address or Prenomes mailing address. Upon receiving the withdrawal request, all
sequencing, medical and sociodemographic data tied to the participant ID will be
removed from the Prenome database and CRM. All saliva, DNA and library samples
tied to that participant will be removed from storage and destroyed immediately.
RISKS TO PARTICIPANTS
The risk to participants from study involvement is minimal. Participants will be
required to refrain from eating or drinking for 30 minutes before sample collection.
Participants will be asked to provide 1ml of saliva into the collection device, this can
be collected over 5-10 minutes. Both of these requirements may cause some
participant discomfort, but do not pose high risk of participant harm or distress.
Participants will be able to collect their saliva samples at home, at a time of their
choice to help negate this discomfort.
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
ETHICAL CONSIDERATION
This study poses a very low risk to participants, as sample collection is non-invasive
and can be done at home reducing risk to unnecessary COVID-19 exposure for a
high risk group. Further, no individual study outcomes will be reported to
participants, as the pregnancy outcomes will already be determined, reducing the
chances of mental stress or harm to participants. The outcomes of this study will
allow for the creation of a predictive test for gestational diabetes. This can be used
by women to mitigate and reduce the potentially dangerous pregnancy outcomes
associated with gestational diabetes such as preterm birth, diabetes later in life and
stillbirth, improving the lives of new mothers and their children.
DATA ANALYSIS
Data generated from sequencing will under-go quality control analysis using the
basespace software platform produced by Illumina. This will be completed
before any other analysis is performed, to ensure high quality DNA sequencing
was successful by assessing the QC30 score, clusters passing filter and error rate
calculated according to the PhiX spike in from illumina platform protocols.
Once data has passed quality control, the reads generated will be aligned to
reference genomes, using illumina’s basespace platform to produce BAM files
containing aligned reads which can be linked to the index barcodes for each
participant. The participant data will be linked to the sequencing data using the
individual barcode assigned at sample collection. This data will not contain
names or full addresses of participants but will contain medical information and
sociodemographic survey information. We will combine the study sequencing
data with public genetic datasets (UKBioBank, BioBank Japan) which contain
information on pregnant women. This information will be analysed for specific
alleles and gene variants that can be linked to gestational diabetes using Python
to identify GWAS data. The GWAS data will then be run through a variety of PRS
algorithms using Python for Prenome’s preprietory algorithm and Allelica for
publicly available PRS algorithms.
Version Date: 05/05/2021
9

Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
DATA MANAGEMENT AND CONFIDENTIALITY
All sequencing data from participant samples will be generated on the NovaSeq
6000. Sequenced data will be transferred from sequencing equipment to password
protected cloud storage. This information will be anonymised and catalogued using
unique identifiers to protect confidentiality. Genome sequencing data will be
checked for quality control management, and then reads will be filtered and
aligned to a reference genome.
These aligned reads will be matched to participant medical records, used to
generate GWAS data and identify linkage of associated alleles or gene variants
which can be correlated with gestational diabetes. This data may be combined with
publicly available whole genome sequencing data such as the UKBiobank and
Biobank Japan. Once variants have been detected, polygenic risk scores will be
generated using publically available algorithms and Prenome’s internal algorithms.
These scores will be tied to sociodemographic risk factors, generated from the
study questionnaire, to calculate a complete risk score composed of genetic and
epigenetic factors. All data outcomes and statistical analyses produced by this
study will be reviewed by a data monitoring committee (DMC).
Throughout the data analysis process, only assigned data scientists will have access
to participant data. All analysis will be performed by Prenome employees, and must
be conducted on company hardware which is encrypted and password protected.
None of the data generated in this study will be shared or sold to third parties. Any
data published to academic or clinical journals will be de-identified and will not
include individual participant information.
ECONOMIC BURDEN TO PARTICIPANTS
There is no cost for participation in this study, all costs related to sample collection,
data generation and analysis will be covered by Prenome.
CONSENT PROCESS
Research study participants will be able to provide consent via an electronic
consent form unless a physical form is requested. This request can be emailed to
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
clinical@prenome.com. All patients recruited will provide electronic consent using
an encrypted online module through Prenome’s websites (www.prenome.com or
www.gestationaldiabetesstudy.com) and stored within a HIPPA certified CRM.
Prenome will have a phone number that visually impaired patients can call to listen
to consent documents prior to signing.
The purpose of participant consent forms and contact forms is to ensure that
participants are fully aware of the study’s methods, goals and risks. The consent
form will be written in clear and understandable language, outlining all steps
involved in the study as well as information on how participants can exit the study.
At any point during the consent process or study, participants can contact Prenome
directly (clinical@prenome.com) to set up a call for information or to ask questions
about this study.
PROTECTED HEALTH INFORMATION (PHI AND HIPAA)
Prenome’s One in Seven Gestational Diabetes Risk Study will involve the
collection of PHI and HIPAA protected information. Specifically, Prenome will be
collecting the participant’s age, geographic location in the form of a zip code, and
medical record numbers used in this study. Further, pregnancy related outcomes
and health data will be extracted from participant medical records or gathered
through the sociodemographic questionnaire. No participant names, detailed
addresses or unauthorized information will be used for data analysis in this study.
Participants will sign a HIPAA and PHI authorization form as part of the consent for
this study. No unauthorized personnel will have access to this information, and this
information will be accessible only on Prenome devices.
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE
10,000 participants will be recruited across partner sites, online advertising and
waitlist registrations. Currently, Prenome has over a thousand women who have
expressed an interest in participating in this study and will undergo recruitment
upon IRB approval.
Prenome’s established waitlist has been accrued from direct
recruitment and women expressing interest through our website sign up portal.
Version Date: 05/05/2021
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Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
The study will have a dedicated team of researchers for a minimum of 1 year. This
will include the Principal Investigator, NGS Scientist, Research Associate, Data
Scientist and a Recruitment Coordinator. Prenome has access to the appropriate
laboratory
space,
sequencing
equipment,
reagents
and
storage
facilities
to
complete the research study. All employees involved will be required to follow SOPs
to conduct research protocols.
MULTI-SITE RESEARCH
Participants will be recruited at multiple external sites for this study. All sites will be
required to sign a IRB authorization agreement, and must follow the protocols for
recruitment
outlined
by Prenome. Sites will identify and register qualifying
participants, and register them using a secured CRM. All external sites will be
provided with the advertising materials created by Prenome for social media based
advertising.
The materials for sample collection will be provided by the lead site, and shipped to
the participant or shipped to external collection sites. All communications with
external sites will be carried out via the secured CRM or through a secure and
confidential Clinical Prenome email address (clinical@prenome.com). This will be
used to notify the lead site of newly recruited participants, reporting any problems
with recruitment, or requests to withdraw from the study.
All samples collected will be processed, stored and analysed at Prenome’s lead
research site. Samples collected in oragene devices which contain stabilizing
reagents, as well as reagents which lyse enveloped viruses. Samples collected in
OCD-100 or OGD-510 saliva tubes will contain a bacteriostatic reagent, which
inhibits the growth of bacteria from time of sample collection to processing. These
stabilizing and securing reagents allow for the sample to be shipped securely to the
lead site using biohazard-cleared shipping and protects against any risk of
SARS-CoV2 transmission. Prenome staff will be responsible for sample accessioning
and tracking throughout the study, external sites will not have access to this
information.
Version Date: 05/05/2021
12

Study Title: One In Seven Gestational Diabetes Study
Sponsor: Prenome
Protocol Number: PRE001/OM001
IRB Submission Number: Pro00049373
Principal Investigator: Dr Barbara Levy
Email: Barbara@prenome.com
Telephone: (650) 338-4931
Address: 500 Lincoln Centre Drive, Foster City, CA 94404
CONFLICT OF INTEREST
Personnel
Role
Declaration of COI
Barbara Levy
Principal
Investigator
Consultant for Flo, AbbVie, Dorsata and Clinical
Professor at UCSD.
Sarah Brozio
Head of
Research
None
Stevie Cline
Cofounder
Consultant for Natera
Brittany
Dismuke
Cofounder
None
REFERENCES
1.
Saravanan, P., 2020., Maternal Gestational diabetes: opportunities for improving
maternal
and
child
health.,
The
Lancet
Diabetes
and
Endocrinology.
https://doi.org/10.1016/S2213-8587(20)30161-3
2.
Rosik, J., et al., 2019., The role of genetics and epigenetics in the pathogenesis of
gestational
diabetes
mellitus.
Annals
of
Human
Genetics.
https://doi.org/10.1111/ahg.12356
3.
Sheikhpore, M., et al., 2020., The interaction between gene profile and obesity in type 2
diabetes: A review., Obesity Medicine. https://doi.org/10.1016/j.obmed.2020.100197
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