RecruitingEarly Phase 1NCT06190158

Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease


Sponsor

Brigham and Women's Hospital

Enrollment

125 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at a condition called subclinical primary aldosteronism — where one of the adrenal glands makes too much of a hormone called aldosterone — and how it may affect kidney health in people with diabetes or prediabetes. **You may be eligible if...** - You are between 18 and 80 years old - You have type 2 diabetes, prediabetes, or elevated blood sugar while on diabetes medications - Your kidney function is mildly or moderately reduced (eGFR 45–89), or you have other kidney risk factors like high blood pressure, obesity, or moderate protein in the urine **You may NOT be eligible if...** - You have type 1 diabetes - Your blood sugar is very poorly controlled (HbA1c 9% or higher) - You have had a stroke, heart attack, or heart failure - Your blood pressure is very high or very low at screening Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOral sodium suppression test

Oral sodium suppression test (\~2 grams of supplemental sodium for 3 days)

DIAGNOSTIC_TESTSaline suppression test

Saline suppression test (2 liters of saline)

DIAGNOSTIC_TESTCaptopril suppression test

Captopril suppression test (50mg of captopril)

DIAGNOSTIC_TESTDexamethasone suppression test

1mg of dexamethasone

DIAGNOSTIC_TESTCosyntropin stimulation test

250mcg of cosyntropin


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT06190158


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