BridgeMD
New treatment option for Type 2 Diabetes
Official title Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease
ClinicalTrials.gov ID: NCT06190158
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- One of the two following 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
You likely can't join 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...
- 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...
See the full eligibility criteria
- 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...
- One of the two following 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.