Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Korábbi kezelés

• 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)
• Active cancer that is being treated with chemotherapeutic agents
• Daily use of prescribed opioid medications
• Illicit drug use (cocaine, heroin, methamphetamine)
• Electrocardiogram that shows evidence of prior myocardial infarction, atrial arrhythmia, left or right bundle branch blocks.

Más betegség

• Type 1 or Type 3 diabetes
• 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
• Known allergy to ACE inhibitors, cosyntropin

Laborértékek

• Hemoglobin A1c ≥ 9%
• 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

Egyéb

• 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
• Pregnancy
• Breast feeding
• Daily use of oral glucocorticoids
• Active use of a mineralocorticoid receptor antagonist

• Age 18-80 years
• 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.
• 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