Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06190158
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Oral sodium suppression test — DIAGNOSTIC_TEST
    Oral sodium suppression test (\~2 grams of supplemental sodium for 3 days)
  • Saline suppression test — DIAGNOSTIC_TEST
    Saline suppression test (2 liters of saline)
  • Captopril suppression test — DIAGNOSTIC_TEST
    Captopril suppression test (50mg of captopril)
  • Dexamethasone suppression test — DIAGNOSTIC_TEST
    1mg of dexamethasone
  • Cosyntropin stimulation test — DIAGNOSTIC_TEST
    250mcg of cosyntropin

Study Details

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 Dates

Start date
May 15, 2024
Status verified
Apr 2025
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: type 2 diabetes at risk for chronic kidney disease
    type 2 diabetes at risk for chronic kidney disease

Primary Outcome Measure

The magnitude of non-suppressible and renin-independent aldosterone production following saline suppression [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Anand Vaidya, MD
[email protected]
6177325666

Find similar trials in Boston, MA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Brigham and Women's Hospital· Boston, MA

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