Actively Recruiting
Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
Led by Brigham and Women's Hospital · Updated on 2025-04-09
125
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Known diagnosis of type 2 diabetes; or unclear diagnosis but hemoglobin A1c 5.7-6.4% on screening while on metformin, SGLT2 inhibitor, or GLP1RA medications; or unclear diagnosis but hemoglobin A1c 6.5-8.9% on screening
- At-risk for developing CKD with 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, or BMI ≥ 30 kg/m2
- At-risk for CKD progression with eGFR 45-60 mL/min/1.73m2
You will not qualify if you...
- Diagnosis of type 1 or type 3 diabetes
- Hemoglobin A1c ≥ 9%
- Inability to safely participate in fasting study visits
- Average blood pressure at screening greater than 150 mmHg systolic or 100 mmHg diastolic
- Screening systolic blood pressure less than 105 mmHg without use of ACE inhibitor or angiotensin receptor blocker
- Inability to safely withdraw ACE inhibitor or angiotensin receptor blocker medication temporarily
- 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 exam
- Active cancer treated with chemotherapy
- Pregnancy or breastfeeding
- Daily use of prescribed opioid medications
- Illicit drug use (cocaine, heroin, methamphetamine)
- Daily use of oral glucocorticoids
- Electrocardiogram showing prior myocardial infarction, atrial arrhythmia, or bundle branch blocks
- Hematocrit less than 32% or hemoglobin less than 10 g/dl (women) or less than 11 g/dl (men) on screening day
- eGFR less than 45 mL/min/1.73m2 on screening day
- Known allergy to ACE inhibitors or cosyntropin
- Active use of a mineralocorticoid receptor antagonist
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
A
Anand Vaidya, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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