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Type 2 diabetesKidney disease

Subclinical Primary Aldosteronism in Diabetes At-Risk for Kidney Disease

Recruiting · Boston, Massachusetts

EARLY_PHASE1

Always free

Study care at no cost to you

For your time and travel

Many studies pay you back

Most need no insurance or papers

Legal status usually isn't required; we'll tell you each study's requirements

Interpreters available

Ask for your language

Your choice

Voluntary — you can stop anytime

What is this study?

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.

It is , overseen by an independent and licensed medical staff.

Read the full clinical 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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • You are between 18 and 80 years old.
  • You have known type 2 diabetes, or your A1c blood test suggests type 2 diabetes while you take certain diabetes medicines (metformin or SGLT2 inhibitors or GLP1 medicines).
  • You are at risk for chronic kidney disease (CKD) based on kidney function and other factors like albumin in urine, high blood pressure or blood pressure treatment, or higher BMI.
  • Or you have lower kidney function showing risk for CKD progression (eGFR 45–60).
  • Your blood pressure and other safety checks at screening allow fasting study visits and you can switch off certain blood pressure medicines if needed.

🚫 You may not be able to join if…

  • You have type 1 or type 3 diabetes.
  • Your A1c is 9% or higher.
  • Your screening blood pressure is too high (over 150 systolic or over 100 diastolic), or too low (under 105 systolic) unless you already use an ACE inhibitor or an ARB.
  • You cannot safely stop an ACE inhibitor or ARB for a few weeks if the study needs an alternative plan.
  • You have certain heart or blood vessel problems (like prior stroke, heart attack, heart failure, aneurysms) or an exam finding suggesting serious valve disease, or you have active cancer being treated with chemotherapy.

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 18–80
  • A BMI around 30 or higher
  • Have Obesity / overweight or Type 2 diabetes or High blood pressure or Kidney disease
  • !Some conditions may not be a fit: Heart / cardiovascular disease
  • !Not for people who are pregnant or breastfeeding

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

This is an early-stage study. The treatment has gone through laboratory and preliminary testing before being studied in people here.

What you need to know before you apply

What is this study 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.

Is it safe? Who makes sure of that?+

This is an early study (Phase 1), focused mostly on safety. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT06190158 · Locations: Massachusetts