An observational study in Diabetes, Heart Disease and Asthma, sponsored by National Institute of Environmental Health Sciences (NIEHS). Recruiting at 2 sites in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational
Among 3,021 studies in Diabetes Mellitus with a site in United States — 288 open to participants now, 389 under way, 12 of them phase 3. Diabetes Mellitus · United States.
Among the 3,021 studies in Diabetes Mellitus with a site in United States, this one is the 24th largest by planned enrollment of the 499 observational ones that give a count, is one of 170 that started in 2010, is one of 507 observational ones, and was the 332nd registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 25,000 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →288 of the 3,021 studies in Diabetes Mellitus with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 18 Years to 120 Years · all sexes · healthy volunteers too.
The full table on the hub →3,021 studies; the count open now beside each. This study's row is marked.
First in 1976; this study’s year is marked. 170 started in 2010.
Median enrollment 82 across the 2,500 interventional studies, 159 across the 499 observational. Of the 2,396 that completed or were terminated, 987 (41%) have results posted.
852 of 3,021 have an industry lead sponsor. The 10 most frequent:
National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 183 studies on the registry; 18 are open to participants now.
National Institute of Environmental Health Sciences (NIEHS) has 3 studies filed under Diabetes Mellitus — fewer than ten, so there is no comparison to draw.
141 of the studies in Diabetes Mellitus with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03982693Phase 3Mt. Sinai Medical Center, MiamiTrial to Assess Chelation Therapy in Critical Limb Ischemia | 2026-12 |
| NCT05174052Phase 3University of OklahomaDapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) | 2027-04 |
| NCT02262832Phase 3National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy | 2027-07-31 |
| NCT07400653Phase 3PfizerA Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D) | 2027-10-12 |
| NCT07556354University of Alabama at BirminghamEmpowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City | 2026-11 |
Among the 3,021 studies in Diabetes Mellitus with a site in United States, from their registry updates:
Despite the overwhelming focus on genetic and genomic causes of human disease over the past two decades, it has been estimated that genetics is currently known to explain only 20% and 40% of the etiology of common disease. Thus, it is becoming increasingly apparent that human disease is a consequence of both genetic susceptibility and environmental exposures. Importantly, while individuals cannot change their genetic composition, we do have the ability both personally and as a society, to influence our environment, promoting health and decreasing the risk of disease. The Personalized Environment and Genes Study (PEGS) aims to determine how the environment and gene-environment interactions can inform our understanding of human health and disease. As science has evolved, so too has the science of this project. This evolution was reflected in a change in the title of this project from the Environmental Polymorphisms Registry (EPR) to the Personalized Environment and Genes Study (PEGS) to more accurately reflect the science that can be conducted. PEGS is a unique resource because of the depth of environmental phenotyping which includes extensive information from exposome surveys, as well as whole genome sequencing on a significant number of participants in the cohort. While it is small relative to genomic cohorts, none of these have the extensive environmental data that is present in PEGS. In addition, other cohorts with deep environmental data lack the depth of genomic data that is present in PEGS. Importantly, PEGS has already provided important analytic advances that are of great interest to and can be confirmed in larger cohorts such as All of Us.
The Personalized Environment and Genes Study (PEGS) aims to provide a resource for environmental health translational research by examining gene-environment interactions in health and disease. PEGS is an extension of two previous efforts where it began as a pilot study, the Environmental Polymorphisms Study (EPS; IRB# 02E9004) and was approved subsequently as a full protocol titled the Environmental Polymorphisms Registry (EPR) (IRB #04-E-N0053 and transitioned to its current ID# 04-E-0053). The EPR was envisioned as a phenotype-by-genotype registry of participants who had donated DNA samples, and who had agreed to be contacted for follow-up clinical translational studies based on their DNA genotypes. At the time, the only information available was a participant s age, sex, race, and ethnicity. Further phenotyping of a participant and/or any biospecimens obtained were investigated during a follow-up translational clinical study on participants recruited based on their genotype (hence phenotype-by-genotype) and the PEGS was the first recruit-by- genotype study at the NIH. Following a period focused on recruiting approximately 15,000 participants to enable genotyping of rare (approximately 1% minor allele frequency) single nucleotide polymorphisms (SNPs), the PEGS Consortium Project was undertaken in 2010- 2011 to examine, using the DNA of nearly 4,000 participants, approximately 700 SNPs in approximately 80 environmental response genes that work in concert with environmental exposures to elicit a phenotype. Several clinical follow-up studies, genotype-phenotype association studies, and publications have resulted from the PEGS Consortium Project.
To expand phenotype information available to researchers, the Health and Exposure Questionnaire was administered between 2013-2014. In 2017, a more detailed Exposome Questionnaire which includes questions relating to the external and internal exposome was administered. This was an important resource through which to integrate exposures with genotype-phenotype association studies.
Whole genome sequencing has now been performed on approximately 4700 participants who were reconsented for this purpose, as indicated above. Questionnaire data was fully adjudicated and combined in a robust and searchable database. With the increased power of the data available, the project was renamed as the Personalized Environment and Genes Study (PEGS) and rolled out in Sept. 2021.
Study Description: The Personalized Environment and Genes Study (PEGS) integrates genetic and environmental data to understand disease etiology, identify disease risk factors, and improve disease prevention.
Objectives: The objective of PEGS is to provide a resource for environmental health translational research by examining environment and gene-environment interactions in health and disease. PEGS will incorporate exposure and health information with or without genomic information to address the following objectives.
Endpoints:
Primary Endpoints:
Dichotomous phenotype (multiple analyses; each analysis is focused on a single dichotomous phenotype of clinical interest,
or a group of mechanistically related dichotomous phenotypes) Example: asthma;
Secondary Endpoints:
Convenience sample from the general population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible for participation in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA
An individual who does not meet the inclusion criteria listed above is excluded from participation in this study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Specimens are available to investigators in coded form to anonymously screen for the presence of single-nucleotide polymorphisms (SNPs) and other mutations in DNA.
Disease
Genetic changes and disease.
Time frame: End of study
Plan to share: Yes — The types of data to be collected are clinical, demographics, medical history, questionnaires, laboratory, health records, and sequencing data. Digital data are collected and stored securely in REDCap, and biological specimens in monitored freezers. Raw data is extracted from REDCap, transformed and combined as needed, and stored in SAS, R, and csv datasets. De-identified data will be shared with IRB-approved researchers conducting genotyping, exposure, or disease-specific callback studies, and these data will be labeled only with PEGS PINs. Any new projects that meet the definition of Human Subjects Research (HSR) will require a separate IRB-approved protocol to receive PII. With participant consent, de identified whole genome or exome data will be submitted to NIH designated repositories such as dbGaP. Follow up studies are separate from PEGS and require scientific, IRB, and PEGS committee review before any personal information is released.
Supporting information: Study protocol, Informed consent form
Time frame: All data generated will be maintained by PEGS while the study remains open and under IRB review. Outside investigators may apply for research collaborations and access to study data throughout this time.
Access criteria: Data is only shared with approved researchers.
Started May 2010 (actual).
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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National Institute of Environmental Health Sciences (NIEHS) →