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Spots Global Cancer Trial Database for Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas

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Trial Identification

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

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

Study ID: NCT02362308

Study Description

Brief 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Vanderbilt University Medical Center, Nashville, Tennessee, United States

Contact Details

Name: James M Luther, MD

Affiliation: Vanderbilt University Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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