Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
NCT06190158 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2025-04-09
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.
Conditions
- Type 2 Diabetes
- Chronic Kidney Diseases
Interventions
- DIAGNOSTIC_TEST
-
Oral sodium suppression test
Oral sodium suppression test (\~2 grams of supplemental sodium for 3 days)
- DIAGNOSTIC_TEST
-
Saline suppression test
Saline suppression test (2 liters of saline)
- DIAGNOSTIC_TEST
-
Captopril suppression test
Captopril suppression test (50mg of captopril)
- DIAGNOSTIC_TEST
-
Dexamethasone suppression test
1mg of dexamethasone
- DIAGNOSTIC_TEST
-
Cosyntropin stimulation test
250mcg of cosyntropin
Sponsors & Collaborators
-
Brigham and Women's Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-15
- Primary Completion
- 2029-07-31
- Completion
- 2029-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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