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Active Not Recruiting NCT06190158

Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Conditions: Type 2 Diabetes, Chronic Kidney Diseases

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 125
Sponsor: Brigham and Women's Hospital

Location: Brigham and Women's Hospital Boston Massachusetts

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 Criteria

Inclusion Criteria: 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 Exclusion Criteria: * 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 \

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Source: ClinicalTrials.gov (NCT06190158). StuddyBuddy aggregates publicly available trial information.