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NCT05631119
Biorepository of Biospecimen Samples in Matched Healthy Control Participants and Participants Diagnosed With Diabetic Kidney Disease, Chronic Kidney Disease, or Type 2 Diabetes
Conditions: Diabetic Kidney Disease, Diabetes Type 2, Chronic Kidney Diseases, Healthy
Sex: All
Ages: 18 Years – 85 Years
Enrollment: 40
Sponsor: Sanguine Biosciences
Summary
The Investigators will generate a repository of human biosamples across therapeutic areas that will be used to identify disease-associated biomarkers and potential targets with immune and multi-omics profiling.
This sample collection and analysis from people living with type 2 diabetes, or chronic or diabetic kidney disease will lay the groundwork for an extensive network of biosample access and linked datasets that will provide an invaluable resource for translational research.
Eligibility Criteria
Cohort 1: Diabetic Kidney DiseaseInclusion:The participant is willing and able to provide written informed consentThe participant is willing and able to provide appropriate photo identificationParticipants aged 18 to 85Participants have been diagnosed with diabetic kidney disease.
Enrollment preference for participants with stage 3 kidney disease but is not inclusionary.Exclusion:Participants who are pregnant or are nursingParticipants with a known history of HIV, hepatitis, or other infectious diseasesParticipants who have taken an investigational product in the last 30 daysParticipants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two monthsCohort 2: Chronic Kidney DiseaseInclusion:The participant is willing and able to provide written informed consentThe participant is willing and able to provide appropriate photo identificationParticipants aged 18 to 85Participants have been diagnosed with chronic kidney disease.Exclusion:Participants who are pregnant or are nursingParticipants with a known history of HIV, hepatitis, or other infectious diseasesParticipants who have taken an investigational product in the last 30 daysParticipants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two monthsParticipants have been diagnosed with acute kidney disease or diabetic kidney diseaseCohort 3: Type 2 DiabetesInclusion:The participant is willing and able to provide written informed consentThe participant is willing and able to provide appropriate photo identificationParticipants aged 18 to 85Participants have been diagnosed with type 2 diabetes.Exclusion:Participants who are pregnant or are nursingParticipants with a known history of HIV, hepatitis, or other infectious diseasesParticipants who have taken an investigational product in the last 30 daysParticipants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two monthsParticipants have been diagnosed with type 1 diabetesCohort 4: Healthy Matched The study will enroll participants considered healthy matched controls per the eligibility criteria.
The healthy-matched controls must match each participant in the diseased cohorts by age (+/- 10 years).Inclusion:1.
The participant is willing and able to provide written informed consent 2. The participant is willing and able to provide appropriate photo identification 3. Participants aged 18 to 85 4. Participants who are in generally good health are defined as: b.
Participants may have a common/mild health condition(s) that are generally under control, including but not limited to: i. Hypertension, high cholesterol, asthma, anxiety, depression, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), allergies, eczema, migraines, osteoarthritis, sleep apnea, restless leg syndrome, and eye issues (e.g., myopia, astigmatism, etc.) ii.
Participants with a previous diagnosis and have recovered from COVID-19 iii.
Participants in general good health may also take nonsteroidal anti-inflammatory drugs (NSAIDS) (i.e., ibuprofen, Tylenol, aspirin, Excedrin) irregularly or semi-regularly due to conditions like headache, body aches, cold/flu treatment as long as the medications are not being used for the treatment of a major underlying condition.Exclusion:Participants who are pregnant or are nursingParticipants with a known history of HIV, hepatitis, or other infectious diseasesParticipants who have taken an investigational product in the last 30 daysParticipants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two monthsParticipants not considered in general good health
Source: ClinicalTrials.gov (NCT05631119). StuddyBuddy aggregates publicly available trial information.