Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Summary

The aim of this protocol is to assess the presence and severity of primary aldosteronism pathophysiology in patients with type 2 diabetes who have, or are at-risk for developing, chronic kidney disease.

Eligibility

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

Conditions3

Locations1 site

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