View Clinical Trial (Medical Research Study)
Aldosterone and Glucose Homeostasis
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Diabetes Mellitus |
| Purpose: |
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Determine the effect of aldosterone on how the body handles glucose (sugar).
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| Study Summary: |
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Determine the effect of aldosterone on glucose metabolism in humans.
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| Criteria: |
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Inclusion Criteria:
1. Ambulatory subjects, 18 to 70 years of age, inclusive
2. For female subjects, the following conditions must be met:
1. postmenopausal status for at least 1 year, or
2. status-post surgical sterilization, or
3. if of childbearing potential, utilization of adequate birth control and
willingness to undergo urine beta-hcg testing prior to drug treatment and on
every study day
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Exclusion Criteria:
1. BMI greater than 31 kg/m2
2. Diabetes type 1 or type 2, a fasting glucose of greater than 110 mg/dL or
the use of anti-diabetic medication
3. Serum triglycerides greater than 150 mg/dL (1.7 mmol/L)
4. Total cholesterol greater than 200 mg/dL (5.18 mmol/L)
5. Use of hormone replacement therapy
6. Statin therapy
7. A seated or supine systolic blood pressure greater than 130/85 on three
separate measurements at least 15 minutes apart
8. Pregnancy
9. Breast-feeding
10. Cardiovascular disease such as myocardial infarction within 6 months prior
to enrollment, presence of angina pectoris, significant arrhythmia (atrial
fibrillation or ventricular tachycardia), 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
11. Treatment with anticoagulants
12. History of serious neurologic disease such as cerebral hemorrhage, stroke,
or transient ischemic attack
13. History or presence of immunological or hematological disorders
14. Diagnosis of asthma requiring use of inhaled beta agonist > 1 time per week
15. Clinically significant gastrointestinal impairment that could interfere
with drug absorption
16. Impaired hepatic function [aspartate amino transaminase (AST) and/or
alanine amino transaminase (ALT) >1.5 x upper limit of normal range]
17. Impaired renal function [estimated glomerular filtration rate (eGFR) of
<60ml/min]
18. Hematocrit <35%
19. 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
20. Treatment with chronic systemic glucocorticoid therapy (more than 7
consecutive days in 1 month)
21. Treatment with lithium salts
22. History of alcohol or drug abuse
23. Treatment with any investigational drug in the 1 month preceding the study
24. Mental conditions rendering the subject unable to understand the nature,
scope and possible consequences of the study
25. Inability to comply with the protocol, e.g. uncooperative attitude,
inability to return for follow-up visits, and unlikelihood of completing
the study
26. Potassium less than 3.5mmol/L or use of chronic potassium supplements.
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| NCT ID: |
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NCT00732160 |
| Primary Contact: |
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Principal Investigator
James M Luther, MD
Vanderbilt University
Loretta Byrne, RN
Phone: 615-322-2105
Email: loretta.byrne@vanderbilt.edu
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| Backup Contact: |
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Email: james.luther@vanderbilt.edu
James Luther, MD
Phone: 615-343-8701
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| Location Contact: |
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Nashville, Tennessee 37232
United States
Loretta Byrne
Phone: 615-322-2105
Email: loretta.byrne@vanderbilt.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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