Hormone clue may unmask kidney danger in diabetes
NCT ID NCT06190158
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
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