Clinical Trial: Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas

Brief Summary: The investigators will test the hypothesis that endogenous aldosterone impairs insulin secretion and insulin sensitivity in subjects with primary aldosteronism.

Detailed Summary:

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.


Sponsor: Vanderbilt University

Current Primary Outcome:

  • Change in Acute Glucose-stimulated Insulin Secretion [ Time Frame: Change from Baseline vs. 3-12 months after intervention ]
    measured by hyperglycemic clamp
  • Change in Insulin Sensitivity Index [ Time Frame: Change from Baseline vs. 3-12 months after intervention ]
    measured by hyperinsulinemic-euglycemic clamp
  • Change in Disposition Index (product of Insulin sensitivity index and acute insulin secretion) [ Time Frame: Change from Baseline vs. 3-12 months after intervention ]
    Product of insulin sensitivity and insulin secretion


Original Primary Outcome: Same as current

Current Secondary Outcome: Suppression of Hepatic glucose production [ Time Frame: Change from Baseline vs. 3-12 months after intervention ]

suppression of hepatic glucose production during hyperinsulinemic clamp, determined using glucose tracer


Original Secondary Outcome: Same as current

Information By: Vanderbilt University

Dates:
Date Received: February 5, 2015
Date Started: January 2015
Date Completion:
Last Updated: August 19, 2016
Last Verified: August 2016