Biorepository of Biospecimen Samples in Matched Healthy Control Participants and Participants Diagnosed With Diabetic Kidney Disease, Chronic Kidney Disease, or Type 2 Diabetes

Biorepository of Biospecimen Samples in Matched Healthy Control Participants and Participants Diagnosed With Diabetic Kidney Disease, Chronic Kidney Disease, or Type 2 Diabetes

Patients diagnosed with Diabetic Kidney Disease, Chronic Kidney Disease, and Diabetes Type 2. The 4th cohort will be a healthy match cohort of patients: 2 of the disease cohorts will have 3 healthy matched patieints and the final disease cohort (unspecified) will have 4 healthy patients matched.
Cohort 1: Diabetic Kidney Disease
Inclusion:

The participant is willing and able to provide written informed consent
The participant is willing and able to provide appropriate photo identification
Participants aged 18 to 85
Participants 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 nursing
Participants with a known history of HIV, hepatitis, or other infectious diseases
Participants who have taken an investigational product in the last 30 days
Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months

Cohort 2: Chronic Kidney Disease
Inclusion:

The participant is willing and able to provide written informed consent
The participant is willing and able to provide appropriate photo identification
Participants aged 18 to 85
Participants have been diagnosed with chronic kidney disease.

Exclusion:

Participants who are pregnant or are nursing
Participants with a known history of HIV, hepatitis, or other infectious diseases
Participants who have taken an investigational product in the last 30 days
Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
Participants have been diagnosed with acute kidney disease or diabetic kidney disease

Cohort 3: Type 2 Diabetes
Inclusion:

The participant is willing and able to provide written informed consent
The participant is willing and able to provide appropriate photo identification
Participants aged 18 to 85
Participants have been diagnosed with type 2 diabetes.

Exclusion:

Participants who are pregnant or are nursing
Participants with a known history of HIV, hepatitis, or other infectious diseases
Participants who have taken an investigational product in the last 30 days
Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
Participants have been diagnosed with type 1 diabetes

Cohort 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 nursing
Participants with a known history of HIV, hepatitis, or other infectious diseases
Participants who have taken an investigational product in the last 30 days
Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
Participants not considered in general good health

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

March 24, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
Comments