Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

NCT06190158 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2023p003466
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• The magnitude of non-suppressible and renin-independent aldosterone production following saline suppression

  The plasma aldosterone concentration following saline suppression testing will serve as a metric quantifying the degree of renin-independent aldosterone production (PA pathophysiology)

  5 years

• The magnitude of non-suppressible and renin-independent aldosterone production following oral sodium suppression.

  The magnitude of non-suppressible and renin-independent aldosterone production measured by urinary aldosterone following oral sodium loading,

  5 years

Study Arms (1)

type 2 diabetes at risk for chronic kidney disease

EXPERIMENTAL

type 2 diabetes at risk for chronic kidney disease

Diagnostic Test: Oral sodium suppression test; Diagnostic Test: Saline suppression test; Diagnostic Test: Captopril suppression test; Diagnostic Test: Dexamethasone suppression test; Diagnostic Test: Cosyntropin stimulation test

Interventions

Oral sodium suppression test DIAGNOSTIC_TEST

Oral sodium suppression test (\~2 grams of supplemental sodium for 3 days)

type 2 diabetes at risk for chronic kidney disease

Saline suppression test DIAGNOSTIC_TEST

Saline suppression test (2 liters of saline)

type 2 diabetes at risk for chronic kidney disease

Captopril suppression test DIAGNOSTIC_TEST

Captopril suppression test (50mg of captopril)

type 2 diabetes at risk for chronic kidney disease

Dexamethasone suppression test DIAGNOSTIC_TEST

1mg of dexamethasone

type 2 diabetes at risk for chronic kidney disease

Cosyntropin stimulation test DIAGNOSTIC_TEST

250mcg of cosyntropin

type 2 diabetes at risk for chronic kidney disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anand Vaidya, MD

CONTACT

16177325666; anandvaidya@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a mechanistic study involving dietary and hormonal interventions to evaluate hormone physiology.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 5, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (1)