Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

This study is looking at how a condition called primary aldosteronism (where your body makes too much of a hormone called aldosterone) might affect people with type 2 diabetes who have, or are at risk for, kidney disease. Researchers will use several diagnostic tests, including the oral sodium suppression test, saline suppression test, captopril suppression test, dexamethasone suppression test, and cosyntropin stimulation test, to understand aldosterone production. The goal is to see if this condition contributes to kidney problems in diabetes. They will measure aldosterone levels after these tests to see how much is produced over 5 years. You may be able to join if you are between 18 and 80 years old and have type 2 diabetes or certain hemoglobin A1c levels.

Study design: This interventional study plans to enroll 125 participants. The phase of the study is not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Researchers will measure aldosterone production at 5 years after the suppression tests.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Active, Not Recruiting

EARLY_PHASE1Ages 18–80Interventional

Brigham and Women's Hospital

~125 participants

Updated 2026-08-13 on ClinicalTrials.gov

What's tested:Oral sodium suppression testSaline suppression testCaptopril suppression testDexamethasone suppression testCosyntropin stimulation test

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

The magnitude of non-suppressible and renin-independent aldosterone production following saline suppression

Measured over 5 years

+1 more outcome measured

Conditions

Type 2 Diabetes

Chronic Kidney Diseases

Where it's being run

1 sites across 1 states

Massachusetts1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

The magnitude of non-suppressible and renin-independent aldosterone production following saline suppression5 years
The plasma aldosterone concentration following saline suppression testing will serve as a metric quantifying the degree of renin-independent aldosterone production (PA pathophysiology)
The magnitude of non-suppressible and renin-independent aldosterone production following oral sodium suppression.5 years
The magnitude of non-suppressible and renin-independent aldosterone production measured by urinary aldosterone following oral sodium loading,

Trialytics