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 range18 Years – 70 Years

SexALL

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.
✕. Prior allergies to medications used in the study protocol (e.g. L-arginine, potassium chloride, insulin), or to drugs within the same class.
✕. Screening plasma potassium \>5.5 mmol/L or sodium \<135 mmol/L
✕. Cardiovascular disease such as recent (\<6 months) myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
✕. Breast-feeding
✕. Treatment with anticoagulants

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 range18 Years – 70 Years

SexALL

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.
✕. Prior allergies to medications used in the study protocol (e.g. L-arginine, potassium chloride, insulin), or to drugs within the same class.
✕. Screening plasma potassium \>5.5 mmol/L or sodium \<135 mmol/L
✕. Cardiovascular disease such as recent (\<6 months) myocardial infarction, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy
✕. Breast-feeding
✕. Treatment with anticoagulants

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