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

Chronic Kidney Diseases Type 2 Diabetes

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

Inclusion Criteria5

Age 18-80 years
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.
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

Exclusion Criteria19

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
Active cancer that is being treated with chemotherapeutic agents
Pregnancy
Breast feeding
Daily use of prescribed opioid medications
Illicit drug use (cocaine, heroin, methamphetamine)
Daily use of oral glucocorticoids
Electrocardiogram that shows evidence of prior myocardial infarction, atrial arrhythmia, left or right bundle branch blocks.
Hematocrit \< 32% or Hemoglobin \< 10 g/dl (women) or Hemoglobin \< 11 g/dl (men) on the day of screening
eGFR \<45 mL/min/1.73m2 on the day of screening
Known allergy to ACE inhibitors, cosyntropin
Active use of a mineralocorticoid receptor antagonist