Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Recruiting now · Early Phase 1

Conditions studied: Type 2 Diabetes, Chronic Kidney Diseases

In brief

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.

Key facts

Study ID

NCT06190158

Run by

Brigham and Women's Hospital

People needed

125

Starts

2024-05-15

Expected to finish

2029-07-31

Last updated by the study team

2025-04-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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