RecruitingType 2 DiabetesChronic Kidney Diseases
Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
Eligible age
18–80 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Brigham and Women's Hospital
You may qualify if…
- ✓ 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
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
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT06190158 · last updated 2025-04-09