Assessing primary aldosteronism in diabetes patients at risk for kidney disease
Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
This study is testing how a hormone called aldosterone affects kidney health in people with type 2 diabetes who are at risk for kidney disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06190158 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the presence and severity of primary aldosteronism in patients with type 2 diabetes who are at risk for chronic kidney disease (CKD). It focuses on understanding how this condition contributes to the progression of CKD and associated cardiovascular risks. Participants will undergo various suppression tests to assess aldosterone production and its effects on kidney health. The findings could lead to improved strategies for preventing CKD in high-risk diabetic patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 with type 2 diabetes who are at risk for developing chronic kidney disease.
Not a fit: Patients with type 1 or type 3 diabetes, or those with poorly controlled diabetes (HbA1c ≥ 9%) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and management of primary aldosteronism, potentially preventing or delaying chronic kidney disease in diabetic patients.
How similar studies have performed: Emerging evidence suggests that understanding primary aldosteronism in this context is a novel approach, with limited prior studies directly addressing this specific patient population.
Eligibility criteria
Show full inclusion / exclusion 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 \<45 mL/min/1.73m2 on the day of screening * Known allergy to ACE inhibitors, cosyntropin * Active use of a mineralocorticoid receptor antagonist
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Anand Vaidya, MD
- Email: anandvaidya@bwh.harvard.edu
- Phone: 16177325666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.