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Hormone clue may unmask kidney danger in diabetes

NCT ID NCT06190158

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This study investigates whether people with type 2 diabetes who have or are at risk for chronic kidney disease produce too much aldosterone, a hormone that regulates salt and blood pressure. Participants undergo several suppression tests—including oral sodium, saline infusion, and medication challenges—to measure how much aldosterone their bodies produce independently of normal triggers. The goal is to understand if this hidden hormone excess is linked to kidney damage, which could lead to better detection and treatment strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Diagnostic tests including oral sodium, saline, captopril, dexamethasone, and cosyntropin to assess aldosterone production
What this could lead to
If this works, it could identify a treatable hormone imbalance that contributes to kidney disease in people with type 2 diabetes, potentially guiding earlier interventions.
What could go wrong
This is an early-phase diagnostic study, so it won't directly test treatments. The tests may not reliably distinguish the condition, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.