Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
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
🗓️ Study Start (Actual) 15 May 2024
🗓️ Primary Completion (Estimated) July 2029
✅ Study Completion (Estimated) September 2029
👥 Enrollment (Estimated) 125
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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 \<45 mL/min/1.73m2 on the day of screening
    • * Known allergy to ACE inhibitors, cosyntropin
    • * Active use of a mineralocorticoid receptor antagonist
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 December 2023
  • First Submitted that Met QC Criteria 2 January 2024
  • First Posted 5 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 June 2024
  • Last Update Posted 28 June 2024
  • Last Verified June 2024