NCT06190158Active, not recruitingEarly phase 1
Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- First submitted
- 18 Dec 2023
- Start date
- 15 May 2024
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT06190158
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 125
- From 15 May 2024 to the primary completion date, 31 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Active cancer that is being treated with chemotherapeutic agents
- Daily use of prescribed opioid medications
- Illicit drug use (cocaine, heroin, methamphetamine)
- Electrocardiogram that shows evidence of prior myocardial infarction, atrial arrhythmia, left or right bundle branch blocks.
Other illness
- Type 1 or Type 3 diabetes
- 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
- Known allergy to ACE inhibitors, cosyntropin
Lab values
- Hemoglobin A1c ≥ 9%
- 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
Other
- 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
- Pregnancy
- Breast feeding
- Daily use of oral glucocorticoids
- Active use of a mineralocorticoid receptor antagonist
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.