We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 18 for:    eplerenone | Recruiting, Not yet recruiting, Available Studies

Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas

This study is currently recruiting participants.
Verified June 2017 by James Matt Luther, Vanderbilt University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02362308
First Posted: February 12, 2015
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Matt Luther, Vanderbilt University
  Purpose
The investigators will test the hypothesis that endogenous aldosterone impairs insulin secretion and insulin sensitivity in subjects with primary aldosteronism.

Condition Intervention
Primary Aldosteronism Other: Adrenalectomy Drug: mineralocorticoid receptor antagonist

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Glucose Metabolism in Subjects With Aldosterone-Producing Adenomas

Resource links provided by NLM:


Further study details as provided by James Matt Luther, Vanderbilt University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: January 2015
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Adrenalectomy
Subjects will undergo assessment before and after adrenalectomy for treatment of primary aldosteronism
Other: Adrenalectomy
Adrenalectomy for treatment of primary aldosteronism, according to standard of care
Medical Therapy
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
Other Names:
  • spironolactone
  • eplerenone

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ambulatory subjects, 18 to 70 years of age, inclusive
  2. For female subjects, the following conditions must be met:

    • postmenopausal status for at least 1 year, or
    • status-post surgical sterilization, or
    • if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing on every study day.
  3. Primary aldosteronism determined by both:

    • Biochemical hyperaldosteronism defined as either:

      1. Plasma aldosterone ≥15 ng/dL
      2. or aldosterone-to-renin ratio of ≥30 if on ACE inhibitor
      3. or aldosterone-to-renin ratio of ≥40 in absence of an ACE inhibitor
    • Positive suppression test defined as either:

      1. failure to suppress aldosterone to <7ng/dL after intravenous 0.9% saline infusion over 2 hours
      2. failure to suppress 24-hour urinary aldosterone excretion to <12 µcg with simultaneously documented urine sodium excretion >200 mmol.

Exclusion Criteria:

- Subjects presenting with any of the following will not be included in the study:

  1. Previously diagnosed type 1 Diabetes
  2. Type II Diabetes, as defined by ADA criteria:

    • Hemoglobin A1C ≥6.5%
    • Fasting plasma glucose ≥126mg/dl (7.0mmol/l)
    • 2-hour 75g oral glucose tolerance test (OGTT) plasma glucose ≥200mg/dl (11.1 mmol/l) d. Current treatment with anti-diabetic medication(s)
  3. 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.
  4. Prior allergies to medications used in the study protocol (e.g. L-arginine, potassium chloride, insulin), or to drugs within the same class.
  5. Screening plasma potassium >5.5 mmol/L or sodium <135 mmol/L
  6. 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
  7. Breast-feeding
  8. Treatment with anticoagulants
  9. History of serious neurologic disease such as cerebral hemorrhage, stroke, seizure, or transient ischemic attack
  10. History or presence of immunological or hematological disorders
  11. Diagnosis of asthma requiring use of inhaled beta agonist >1 time per week
  12. Clinically significant gastrointestinal impairment that could interfere with drug absorption
  13. Impaired hepatic function [aspartate amino transaminase (AST) and/or alanine amino transaminase (ALT) >2.0 x upper limit of normal range]
  14. Hematocrit <35%
  15. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult, such as arthritis treated with non-steroidal antiinflammatory drugs
  16. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)
  17. Treatment with lithium salts
  18. History of alcohol or drug abuse
  19. Treatment with any investigational drug in the 1 month preceding the study
  20. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
  21. Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Loretta Byrne, RN 615-322-2105 loretta.byrne@vanderbilt.edu
Contact: Holly Waldrop 615-343-6161 holly.waldrop@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Loretta Byrne, RN    615-322-2105    loretta.byrne@vanderbilt.edu   
Contact: Holly Waldrop    615-343-6161    holly.waldrop@vanderbilt.edu   
Principal Investigator: James M Luther, MD, MSCI         
Sponsors and Collaborators
Vanderbilt University
Brigham and Women's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: James M Luther, MD Vanderbilt University Medical Center
  More Information

Responsible Party: James Matt Luther, James M Luther MD, MSCI, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02362308     History of Changes
Other Study ID Numbers: 141553
R01DK096994 ( U.S. NIH Grant/Contract )
First Submitted: February 5, 2015
First Posted: February 12, 2015
Last Update Posted: June 27, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Adenoma
Hyperaldosteronism
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Mineralocorticoids
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Hormones


To Top