CompletedNot Applicable

Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas

United States10 participantsStarted 2015-01

Plain-language summary

This observational study tests the hypothesis that endogenous aldosterone impairs insulin secretion and insulin sensitivity in subjects with primary aldosteronism.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ambulatory subjects, 18 to 70 years of age, inclusive
. For female subjects, the following conditions must be met:
. Primary aldosteronism determined by both:
. Plasma aldosterone ≥15 ng/dL
. or aldosterone-to-renin ratio of ≥30 if on ACE inhibitor
. or aldosterone-to-renin ratio of ≥40 in absence of an ACE inhibitor
. failure to suppress aldosterone to \<7ng/dL after intravenous 0.9% saline infusion over 2 hours
. failure to suppress 24-hour urinary aldosterone excretion to \<12 µcg with simultaneously documented urine sodium excretion \>200 mmol.

Exclusion criteria

. Previously diagnosed type 1 Diabetes
. Type II Diabetes, as defined by ADA criteria:
. Impaired renal function \[estimated glomerular filtration rate (eGFR) of \<30ml/min\] as determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine (Scr) is expressed in mg/dl and age in years.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Acute Glucose-stimulated Insulin Secretion

Timeframe: Change from Baseline vs. 3-12 months after intervention

Change in Insulin Sensitivity Index

Timeframe: Change from Baseline vs. 3-12 months after intervention

Change in Disposition Index (product of Insulin sensitivity index and acute insulin secretion)

Timeframe: Change from Baseline vs. 3-12 months after intervention

Trial details

NCT IDNCT02362308

SponsorVanderbilt University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01

View on ClinicalTrials.gov More Primary Aldosteronism trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ambulatory subjects, 18 to 70 years of age, inclusive
. For female subjects, the following conditions must be met:
. Primary aldosteronism determined by both:
. Plasma aldosterone ≥15 ng/dL
. or aldosterone-to-renin ratio of ≥30 if on ACE inhibitor
. or aldosterone-to-renin ratio of ≥40 in absence of an ACE inhibitor
. failure to suppress aldosterone to \<7ng/dL after intravenous 0.9% saline infusion over 2 hours
. failure to suppress 24-hour urinary aldosterone excretion to \<12 µcg with simultaneously documented urine sodium excretion \>200 mmol.

Exclusion criteria

. Previously diagnosed type 1 Diabetes
. Type II Diabetes, as defined by ADA criteria:
. Impaired renal function \[estimated glomerular filtration rate (eGFR) of \<30ml/min\] as determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine (Scr) is expressed in mg/dl and age in years.

What they're measuring

Change in Acute Glucose-stimulated Insulin Secretion

Timeframe: Change from Baseline vs. 3-12 months after intervention

Change in Insulin Sensitivity Index

Timeframe: Change from Baseline vs. 3-12 months after intervention

Change in Disposition Index (product of Insulin sensitivity index and acute insulin secretion)

Timeframe: Change from Baseline vs. 3-12 months after intervention