Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT06190158
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-80 years
2. Known diagnosis of type 2 diabetes; or unknown/unclear diagnosis of type 2 diabetes but hemoglobin A1c 5.7-6.4% on screening while on treatment with metformin or SGLT2 inhibitor or GLP1RA class of medications; or unknown/unclear diagnosis of type 2 diabetes but hemoglobin A1c 6.5-8.9% on screening.
3. One of the two following inclusion criteria i. At-risk for developing CKD: eGFR 60-89 mL/min/1.73m2 plus at least one of the following:
* Moderate albuminuria (30-300 mg/g)
* Diagnosis of hypertension or active treatment with anti-hypertensive medications
* BMI ≥ 30 kg/m2 ii. At-risk for CKD progression: eGFR 45-60 mL/min/1.73m2
Exclusion Criteria:
* Type 1 or Type 3 diabetes
* Hemoglobin A1c ≥ 9%
* Inability to safely participate in fasting study visits (determination at the discretion of PI and MD study staff based on cumulative assessment of safety factors)
* Average blood pressure at screening visit of \>150 mmHg systolic or \>100 mmHg diastolic
* Screening average systolic blood pressure less than 105 mmHg without the use of an ACE inhibitor or angiotensin receptor blocker
* Inability to safely withdraw ACE inhibitor or angiotensin receptor blocker medication in lieu of alternative medication for a few weeks (determination at the discretion of PI and MD study staff based on cumulative assessment of factors)
* Known history of stroke, symptomatic coronary artery disease, myocardial infarction, heart failure, cerebral or aortic aneurysm.
* Known cardiac murmur suggestive of aortic stenosis or mitral regurgitation, or detected newly on screening physical examination
* Active cancer that is being treated with chemotherapeutic agents
* Pregnancy
* Breast feeding
* Daily use of prescribed opioid medications
* Illicit drug use (cocaine, heroin, methamphetamine)
* Daily use of oral glucocorticoids
* Electrocardiogram that shows evidence of prior myocardial infarction, atrial arrhythmia, left or right bundle branch blocks.
* Hematocrit \< 32% or Hemoglobin \< 10 g/dl (women) or Hemoglobin \< 11 g/dl (men) on the day of screening
* eGFR \<45 mL/min/1.73m2 on the day of screening
* Known allergy to ACE inhibitors, cosyntropin
* Active use of a mineralocorticoid receptor antagonist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06190158
Study Brief:
Protocol Section:
NCT06190158