NCT02362308

Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The week of each study period, subjects will be provided a standard 160mmol/d sodium diet for 6-8 days to control for inter-individual sodium intake. In period 1, subjects will report after 5 days of controlled sodium diet for a hyperglycemic clamp study (to measure insulin secretion). Subjects will continue the study diet, and then return for a hyperinsulinemic-euglycemic clamp study (to measure insulin sensitivity). After completion of period 1 assessment, subjects will undergo adrenalectomy by our endocrine surgeons or initiate medical treatment, according to routine clinical care. In period 2, the investigators will repeat the studies in the same manner as period 1, 3 to 12 months after adrenalectomy or initiation of medical treatment.

Conditions

• Primary Aldosteronism

Interventions

Type	Name	Description
OTHER	Adrenalectomy	Adrenalectomy for treatment of primary aldosteronism, according to standard of care
DRUG	mineralocorticoid receptor antagonist	Subjects will be treated with a mineralocorticoid receptor antagonist according to standard of care

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2015-02-12
• Last updated: 2021-05-04

Locations

1 site across 1 country: United States