Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls (BRISK 2)
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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
South Carolina
-
Orangeburg, South Carolina, Forenede Stater, 29118
- Rekruttering
- Clemson Health Clinic at Orangeburg
-
Kontakt:
- Katie Poplin
- Telefonnummer: 864-656-4503
- E-mail: kpoplin@clemson.edu
-
Kontakt:
- Jeremy Shields
- Telefonnummer: 864-656-4503
- E-mail: jnshiel@clemson.edu
-
Ledende efterforsker:
- Peter Carek, MD
-
Walhalla, South Carolina, Forenede Stater, 29691
- Rekruttering
- Clemson Health Clinic at Walhalla
-
Kontakt:
- Katie Poplin
- Telefonnummer: 864-656-4503
- E-mail: kpoplin@clemson.edu
-
Kontakt:
- Jeremy Shields
- Telefonnummer: 864-656-4503
- E-mail: jnshiel@clemson.edu
-
Ledende efterforsker:
- Peter Carek, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
INCLUSION CRITERIA:
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:
• 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
EXCLUSION CRITERIA:
- 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
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Type 2 Diabetes
SC Medicaid-enrolled Type 2 Diabetes Patients
|
Non-interventional biospecimen and data collection study.
|
|
Healthy Controls
SC Medicaid-enrolled non-T2D Patients
|
Non-interventional biospecimen and data collection study.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: Up to 24 months after enrollment
|
Perform omics and clinical labs on blood and stool, administer surveys, and analyze medical record data
|
Up to 24 months after enrollment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Randy Axelrod, MD, Guardian Research Network, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BRISK-T2D-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .