[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07731399":3,"trial-entities:NCT07731399":104,"trial-summary:NCT07731399":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":41,"healthy_volunteers":42,"eligibility_criteria":43,"std_ages":62,"locations":65,"central_contacts":98,"overall_officials":99,"references":102,"see_also_links":103},"NCT07731399","BRISK-T2D-001","Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls","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)","RECRUITING","2029-10","2026-07","2026-07-29","Guardian Research Network, Inc.","OTHER",false,"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\u002Fbehavioral data to identify data elements or combinations of data elements with strong positive or negative correlation to CKD diagnosis and\u002For 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.","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.\n\nTo 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).\n\nThis 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\u002Fbehavioral 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.\n\nPatients 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.",[18,19],"Type 2 Diabetes","Healthy (Controls)",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},1200,"ESTIMATED",[28],{"type":13,"name":29,"description":30,"armGroupLabels":31},"Not applicable- observational study","Non-interventional biospecimen and data collection study.",[32,18],"Healthy Controls",[34],{"measure":35,"description":36,"timeFrame":37},"Identify data elements or combinations of data elements with strong positive or negative correlation to Chronic Kidney Disease diagnosis and\u002For progression in Type 2 Diabetes patients","Perform omics and clinical labs on blood and stool, administer surveys, and analyze medical record data","Up to 24 months after enrollment",[],"ALL","40 Years","70 Years",true,{"inclusion":44,"exclusion":51,"raw_text":61},[45,46,47,48,49,50],"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.","Blood level of hemoglobin A1c less than or equal to 5.6% at time of enrollment","No diagnosis of Type 2 diabetes",[52,53,54,55,56,57,58,59,60],"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\u002For 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","INCLUSION CRITERIA:\n\nAll Participants:\n\n* 40 to 70 years of age (inclusive) at enrollment\n* Enrolled as Medicaid recipients\n* Ability to provide informed consent and authorization for release of relevant protected health information or personal data\n* Ability to provide a blood sample(s) of up to 70 mL and other required biospecimens, including genetic samples.\n\nT2D Group:\n\n• 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\n\nControl Group:\n\n* Blood level of hemoglobin A1c less than or equal to 5.6% at time of enrollment\n* No diagnosis of Type 2 diabetes\n\nEXCLUSION CRITERIA:\n\n* Pregnancy at time of enrollment (by self-report of pregnancy status)\n* Lack of fluency in spoken and written English\n* Type 1 diabetes or any other type of diabetes besides Type 2 diabetes\n* 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\u002For squamous cell carcinoma of skin)\n* Major Adverse Cardiovascular Events within two (2) years prior to enrollment\n* Chronic Obstructive Pulmonary Disease\n* Cognitive impairment or neurodegenerative diseases (e.g., Alzheimer's disease, dementia, multiple sclerosis, Parkinson's disease, etc.)\n* Pancreatitis or other diseases of the pancreas (besides diabetes)\n* The participant is, in the opinion of the investigator, unlikely to be able to complete all study requirements",[63,64],"ADULT","OLDER_ADULT",[66,87],{"facility":67,"status":8,"city":68,"state":69,"zip":70,"country":71,"contacts":72,"geoPoint":84},"Clemson Health Clinic at Orangeburg","Orangeburg","South Carolina","29118","United States",[73,78,81],{"name":74,"role":75,"phone":76,"email":77},"Katie Poplin","CONTACT","864-656-4503","kpoplin@clemson.edu",{"name":79,"role":75,"phone":76,"email":80},"Jeremy Shields","jnshiel@clemson.edu",{"name":82,"role":83},"Peter Carek, MD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},33.49182,-80.85565,{"facility":88,"status":8,"city":89,"state":69,"zip":90,"country":71,"contacts":91,"geoPoint":95},"Clemson Health Clinic at Walhalla","Walhalla","29691",[92,93,94],{"name":74,"role":75,"phone":76,"email":77},{"name":79,"role":75,"phone":76,"email":80},{"name":82,"role":83},{"lat":96,"lon":97},34.76482,-83.06404,[],[100],{"name":101,"affiliation":12,"role":83},"Randy Axelrod, MD",[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":42,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an observational study planning to enroll 1200 participants, including those with Type 2 Diabetes and healthy controls.","completed","Observational Study on Type 2 Diabetes and Kidney Disease in South Carolina Medicaid Patients","This study is looking at information from South Carolina Medicaid patients with Type 2 Diabetes (T2D) and healthy individuals. It's an observational study, meaning researchers will collect health data and blood samples, but you won't receive any new treatments. The goal is to find connections between different health information and the diagnosis or progression of chronic kidney disease (CKD) in people with T2D. By understanding these connections, doctors hope to better predict and potentially prevent or treat T2D and its complications. You may be able to join if you are between 40 and 70 years old, a Medicaid recipient, and can provide blood samples.","Researchers will look at data for up to 24 months after you enroll to identify correlations with chronic kidney disease.",104,"You would need to provide informed consent, authorize release of health information, and give blood samples (up to 70 mL) and other genetic samples.","Not stated in the trial record.",[],"v2"]