Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas
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|ClinicalTrials.gov Identifier: NCT02362308|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2015
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Primary Aldosteronism||Other: Adrenalectomy Drug: mineralocorticoid receptor antagonist||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Subjects will undergo assessment before and after adrenalectomy for treatment of primary aldosteronism
Adrenalectomy for treatment of primary aldosteronism, according to standard of care
Subjects will undergo assessment before and after medical treatment of primary aldosteronism
Drug: mineralocorticoid receptor antagonist
Subjects will be treated with a mineralocorticoid receptor antagonist according to standard of care
- 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
- 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
- Urinary exosomal biomarkers [ Time Frame: Change from Baseline vs. 3-12 months after intervention ]Urinary biomarkers of renal sodium channels and sodium transporters
- Associative learning Memory testing [ Time Frame: Change from Baseline vs. 3-12 months after intervention ]Associative learning task matching images and words
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362308
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||James M Luther, MD||Vanderbilt University Medical Center|