Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men
NCT ID: NCT01294319
Last Updated: 2024-07-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2011-01-24
2016-08-10
Brief Summary
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Detailed Description
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Subjects will collect saliva during two evenings before additional testing, and will on the same evening collect urine for twelve hours, both for cortisol measurements. Blood samples will be collected to evaluate the response to dexamethasone. We also will assess ACTH and cortisol responses to medications that reduce negative inhibition of ACTH. This testing will occur in the evening and will include administration of the glucocorticoid antagonist mifepristone, the mineralocorticoid antagonist spironolactone, and/or a look-alike tablet, on four occasions.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Sedentary young adults, SMCP
Spironolactone, Then Mifepristone, Then Combined, Then Placebo (SMCP), Then Dexamethasone
Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Endurance-trained young athletes, SMCP
Spironolactone, Then Mifepristone, Then Combined, Then Placebo (SMCP), Then Dexamethasone
Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Sedentary young adults, MSPC
Mifepristone, Then Spironolactone, Then Placebo, Then Combined (MSPC), Then Dexamethasone
Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Endurance-trained young athletes, MSPC
Mifepristone, Then Spironolactone, Then Placebo, Then Combined (MSPC), Then Dexamethasone
Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Sedentary young adults, CPSM
Combined, Then Placebo, Then Spironolactone, Then Mifepristone (CPSM), Then Dexamethasone
Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Endurance-trained young athletes, CPSM
Combined, Then Placebo, Then Spironolactone, Then Mifepristone (CPSM), Then Dexamethasone
Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Sedentary young adults,PCMS
Placebo, Then Combined, Then Mifepristone, Then Spironolactone (PCMS), Then Dexamethasone
Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Endurance-trained young athletes,PCMS
Placebo, Then Combined, Then Mifepristone, Then Spironolactone (PCMS), Then Dexamethasone
Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Interventions
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Mifepristone
Placebo
Spironolactone
Combined
Dexamethasone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Sedentary:
* Less than one hour physical activity per week for three years
* No change in exercise anticipated for 6 weeks
Trained:
* Greater than 45km (28 miles) running per week for at least 3 months
* No change in exercise anticipated for 6 weeks
For all participants:
* All races
* Sleep-wake cycle with sleeping at night, wakening between 5 and 8 AM
* BMI between 18 and 25 kg/M2
* Normal TSH and free T4
Exclusion Criteria
* Sleep disorders as assessed by sleep apnea questionnaire
* Smoking
* No more than 2 servings of alcohol daily
* Medications known to affect the HPA axis or steroid metabolism, including narcotics, Glucocorticoids, megace or CYP3A4 modulators
* History of psychiatric or endocrine disorders
* Marijuana or other illicit drug use
* Recent appendicular or skeletal injury
* Uncontrolled hypertension
* Chronic pain requiring daily medication
* Current treatment with medications related to mineralocorticoid function such as potassium, ACE-inhibitors, ARBs, diuretics, spironolactone
* Frailty score of 4-7 on the Canadian Study of Health and Aging frailty scale (Rockman 2005)
* Overtraining syndrome will be an exclusion and will be assessed by questionnaire
* Abnormal creatinine level (greater than 1.2 mg/dl)
* Liver function tests greater than two fold normal
* Benzodiazepine use
18 Years
80 Years
MALE
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Lynnette K Nieman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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Bauer ME. Stress, glucocorticoids and ageing of the immune system. Stress. 2005 Mar;8(1):69-83. doi: 10.1080/10253890500100240.
Bertagna X, Bertagna C, Luton JP, Husson JM, Girard F. The new steroid analog RU 486 inhibits glucocorticoid action in man. J Clin Endocrinol Metab. 1984 Jul;59(1):25-8. doi: 10.1210/jcem-59-1-25.
Booth CK, Probert B, Forbes-Ewan C, Coad RA. Australian army recruits in training display symptoms of overtraining. Mil Med. 2006 Nov;171(11):1059-64. doi: 10.7205/milmed.171.11.1059.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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11-CH-0078
Identifier Type: OTHER
Identifier Source: secondary_id
110078
Identifier Type: -
Identifier Source: org_study_id
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