Type 2 DiabetesBRISK 2NCT07731399
Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls
An observational study of Type 2 Diabetes and Healthy (Controls), run by Guardian Research Network, Inc. at 2 sites in United States.
Trial summary
The primary purpose of this study is to use multiomic data in combination with clinical assessments, electronic health records, cognitive and mood assessments, wearable technologies and lifestyle/behavioral data to identify data elements or combinations of data elements with strong positive or negative correlation to… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Healthy (Controls)
- What is being tested?
- Not applicable- observational study
- How many people
- 1,200 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2026to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: South Carolina Medicaid-enrolled participants
Who may be able to join
- All Participants:
- 40 to 70 years of age (inclusive) at enrollment
- Enrolled as Medicaid recipients
- Ability to provide informed consent and authorization for release of relevant protected health information or personal data
- Ability to provide a blood sample(s) of up to 70 mL and other required biospecimens, including genetic samples.
- T2D Group:
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- Current diagnosis of Type 2 diabetes OR a blood level of hemoglobin A1c equal to or greater than 6.5% at any time within the past 12 months
- Control Group:
- Blood level of hemoglobin A1c less than or equal to 5.6% at time of enrollment
- No diagnosis of Type 2 diabetes
Who cannot join
- Pregnancy at time of enrollment (by self-report of pregnancy status)
- Lack of fluency in spoken and written English
- Type 1 diabetes or any other type of diabetes besides Type 2 diabetes
- Active cancer diagnosis or cancer that achieved complete remission within three (3) years prior to enrollment, other than non-melanoma skin cancer (e.g. malignant basal cell neoplasm of skin and/or squamous cell carcinoma of skin)
- Major Adverse Cardiovascular Events within two (2) years prior to enrollment
- Chronic Obstructive Pulmonary Disease
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- Cognitive impairment or neurodegenerative diseases (e.g., Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, etc.)
- Pancreatitis or other diseases of the pancreas (besides diabetes)
- The participant is, in the opinion of the investigator, unlikely to be able to complete all study requirements
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Clemson Health Clinic at Orangeburg
Orangeburg, South Carolina, 29118
Katie Poplin, 864-656-4503, kpoplin@clemson.edu
Jeremy Shields, 864-656-4503, jnshiel@clemson.edu
- Recruiting
Clemson Health Clinic at Walhalla
Walhalla, South Carolina, 29691
Katie Poplin, 864-656-4503, kpoplin@clemson.edu
Jeremy Shields, 864-656-4503, jnshiel@clemson.edu
About this study
Official title: An Observational Clinical Research Study Assembling and Analyzing Highly Complex, Multi-dimensional Molecular and Clinical Data With a Focus on High-risk Diabetes Patients in South Carolina, in Support of the Biomedical Research Initiative for Scientific Knowledge (BRISK)
The primary purpose of this study is to use multiomic data in combination with clinical assessments, electronic health records, cognitive and mood assessments, wearable technologies and lifestyle/behavioral data to identify data elements or combinations of data elements with strong positive or negative correlation to CKD diagnosis and/or progression in Type 2 Diabetes (T2D) patients. Achieving this aim will allow researchers and physicians to significantly improve the prediction of health trajectories of and formulate novel strategies to potentially prevent, treat or reverse T2D. South Carolina Medicaid-enrolled patients diagnosed with T2D and a smaller subset of non-T2D SC Medicaid patients may participate in this study. Participants who complete required procedures will be compensated for their time and transportation, may keep their study-provided Fitbit device to help maintain their healthcare improvement journey, and will have a personal Certified Diabetes Educator to consult and assist with managing their diabetes diagnosis.
Read the detailed description
Diabetes, and in particular Type 2 Diabetes which accounts for roughly 90-95% of Diabetes patients, affects tens of millions of Americans. The state of South Carolina has one of the highest rates of diabetes patients affecting every 1 in 7 adults. In addition, diabetes patients have a very high risk of developing further complications like chronic kidney disease or cardiovascular disease, which besides further threatening the lives of these patients, is very expensive to manage and treat. South Carolina also has one of the highest population growth percentage rate across the US, but the growth of the healthcare workforce particularly in the rural areas of the state is not able to keep up.
To help mitigate this, the SC Department of Health and Human Services has developed a "Rural Health Initiative" to better meet underserved communities' medical needs. Spartanburg Regional Healthcare System and Guardian Research Network have been funded by SCDHHS to serve the first study in this Initiative targeting Type 2 Diabetes (T2D).
This study aims to collect multiple types of data from SC Medicaid-enrolled type 2 diabetes (T2D) patients and healthy patients, including data from biospecimens, questionnaires, cognitive "brain" games, clinical assessments, electronic health records, wearable devices and lifestyle/behavioral data to identify elements that may be related to Chronic Kidney Disease (CKD) diagnosis or T2D progression. The primary goal is for researchers and physicians to analyze the multi-dimensional data to significantly improve the prediction of and strategies to prevent disease progression in T2D patients.
Patients between ages 40 to 70 diagnosed with T2D and enrolled in SC Medicaid may be eligible, as well as a smaller healthy (control) cohort also enrolled in SC Medicaid. Patients will be asked to provide a blood, saliva and stool sample, answer questionnaires, complete online cognitive assessments ("brain games"), and wear a study-provided Fitbit device. Type 2 Diabetes participants will also have access to a Certified Diabetes Educator to assist with disease management and potential suggested lifestyle changes to help improve health.
- Conditions
- Type 2 Diabetes, Healthy (Controls)
- Being tested
- Not applicable- observational study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Non-interventional biospecimen and data collection study.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | SC Medicaid-enrolled Type 2 Diabetes Patients Receives: Other: Not applicable- observational study | |
| Healthy Controls | SC Medicaid-enrolled non-T2D Patients Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify data elements or combinations of data elements with strong positive or negative correlation to Chronic Kidney Disease diagnosis and/or progression in Type 2 Diabetes patients
Perform omics and clinical labs on blood and stool, administer surveys, and analyze medical record data
Measured: Up to 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guardian Research Network, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- South Carolina Department of Health and Human Services, Spartanburg Regional Healthcare System
- Responsible party
- Sponsor
- Investigators
- Randy Axelrod, MD, Principal investigator, Guardian Research Network, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731399
- Sponsor's protocol ID
- BRISK-T2D-001
- Acronym
- BRISK 2
- Status last verified
- Aug 2026
- First submitted
- 16 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Research Study Assembling and Analyzing Highly Complex, Multi-dimensional Molecular and Clinical Data With a Focus on High-risk Diabetes Patients in South Carolina, in Support of the Biomedical Research Initiative for Scientific Knowledge (BRISK)
- ClinicalTrials.gov ID
- NCT07731399
- Acronym / sponsor ID
- BRISK 2 / BRISK-T2D-001
- Conditions
- Type 2 Diabetes, Healthy (Controls)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Guardian Research Network, Inc.University, hospital or other
- Collaborators
- South Carolina Department of Health and Human Services, Spartanburg Regional Healthcare System
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 28 Jul 2026 (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 primary purpose of this study is to use multiomic data in combination with clinical assessments, electronic health records, cognitive and mood assessments, wearable technologies and lifestyle/behavioral data to identify data elements or combinations of data elements with strong positive or negative correlation to CKD diagnosis and/or progression in Type 2 Diabetes (T2D) patients. Achieving this aim will allow researchers and physicians to significantly improve the prediction of health trajectories of and formulate novel strategies to potentially prevent, treat or reverse T2D. South Carolina Medicaid-enrolled patients diagnosed with T2D and a smaller subset of non-T2D SC Medicaid patients may participate in this study. Participants who complete required procedures will be compensated for their time and transportation, may keep their study-provided Fitbit device to help maintain their healthcare improvement journey, and will have a personal Certified Diabetes Educator to consult and assist with managing their diabetes diagnosis.
Detailed description
Diabetes, and in particular Type 2 Diabetes which accounts for roughly 90-95% of Diabetes patients, affects tens of millions of Americans. The state of South Carolina has one of the highest rates of diabetes patients affecting every 1 in 7 adults. In addition, diabetes patients have a very high risk of developing further complications like chronic kidney disease or cardiovascular disease, which besides further threatening the lives of these patients, is very expensive to manage and treat. South Carolina also has one of the highest population growth percentage rate across the US, but the growth of the healthcare workforce particularly in the rural areas of the state is not able to keep up.
To help mitigate this, the SC Department of Health and Human Services has developed a "Rural Health Initiative" to better meet underserved communities' medical needs. Spartanburg Regional Healthcare System and Guardian Research Network have been funded by SCDHHS to serve the first study in this Initiative targeting Type 2 Diabetes (T2D).
This study aims to collect multiple types of data from SC Medicaid-enrolled type 2 diabetes (T2D) patients and healthy patients, including data from biospecimens, questionnaires, cognitive "brain" games, clinical assessments, electronic health records, wearable devices and lifestyle/behavioral data to identify elements that may be related to Chronic Kidney Disease (CKD) diagnosis or T2D progression. The primary goal is for researchers and physicians to analyze the multi-dimensional data to significantly improve the prediction of and strategies to prevent disease progression in T2D patients.
Patients between ages 40 to 70 diagnosed with T2D and enrolled in SC Medicaid may be eligible, as well as a smaller healthy (control) cohort also enrolled in SC Medicaid. Patients will be asked to provide a blood, saliva and stool sample, answer questionnaires, complete online cognitive assessments ("brain games"), and wear a study-provided Fitbit device. Type 2 Diabetes participants will also have access to a Certified Diabetes Educator to assist with disease management and potential suggested lifestyle changes to help improve health.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | Other: Not applicable- observational studySC Medicaid-enrolled Type 2 Diabetes Patients |
| Healthy Controls | – | Other: Not applicable- observational studySC Medicaid-enrolled non-T2D Patients |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- South Carolina Medicaid-enrolled participants
Key inclusion criteria (10 listed)
- 40 to 70 years of age (inclusive) at enrollment
- Enrolled as Medicaid recipients
- Ability to provide informed consent and authorization for release of relevant protected health information or personal data
- Ability to provide a blood sample(s) of up to 70 mL and other required biospecimens, including genetic samples.
- Current diagnosis of Type 2 diabetes OR a blood level of hemoglobin A1c equal to or greater than 6.5% at any time within the past 12 months
Key exclusion criteria (9 listed)
- Pregnancy at time of enrollment (by self-report of pregnancy status)
- Lack of fluency in spoken and written English
- Type 1 diabetes or any other type of diabetes besides Type 2 diabetes
- Active cancer diagnosis or cancer that achieved complete remission within three (3) years prior to enrollment, other than non-melanoma skin cancer (e.g. malignant basal cell neoplasm of skin and/or squamous cell carcinoma of skin)
- Major Adverse Cardiovascular Events within two (2) years prior to enrollment
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 |
|---|---|---|
| Not applicable- observational studyNon-interventional biospecimen and data collection study. | Other | Healthy Controls, Type 2 Diabetes |
Primary outcome
Identify data elements or combinations of data elements with strong positive or negative correlation to Chronic Kidney Disease diagnosis and/or progression in Type 2 Diabetes patients
Time frame: Up to 24 months after enrollment
Perform omics and clinical labs on blood and stool, administer surveys, and analyze medical record data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Randy Axelrod, MD principal investigator
Guardian Research Network, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Healthy (Controls), run by Guardian Research Network, Inc. at 2 sites 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 10 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify data elements or combinations of data elements with strong positive or negative correlation to Chronic Kidney Disease diagnosis and/or progression in Type 2 Diabetes patients (time frame: Up to 24 months after enrollment). 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 18 Aug 2026.