RECRUITING

Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Quick Facts

Study Start:2024-05-15

Study Completion:2029-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06190158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Anand Vaidya, MD

CONTACT

16177325666

anandvaidya@bwh.harvard.edu

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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

Study Start Date2024-05-15

Study Completion Date2029-09

Study Record Updates

Study Start Date2024-05-15

Study Completion Date2029-09

Terms related to this study

Additional Relevant MeSH Terms

Type 2 Diabetes
Chronic Kidney Diseases