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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men

NCTNCT01294319 (opens ClinicalTrials.gov in a new tab)Other id110078Other id11-CH-0078
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names ACTH (corticotropin), does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Phase 2
Enrollment
51 participants (actual)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Nih
Design
Randomized · Triple masking
Countries
1 country

United States

Start
24 Jan 2011
Primary completion
10 Aug 2016
Completion
10 Aug 2016
First posted
11 Feb 2011 (estimated)
Last update posted
15 Jul 2024
Conditions
Cortisol Resistance · Negative Feedback · ACTH · Mineralcorticoid · Glucocorticoid

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014201520162017
  1. Ph 2

    Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men

    NCT01294319

    24 Jan 2011 to 10 Aug 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study proposes to examine multiple aspects of the hypothalamic-pituitary-adrenal axis in younger endurance trained and sedentary men, and in older sedentary men.

Interventions

  • MifepristoneDrug
  • PlaceboDrug
  • SpironolactoneDrug
  • CombinedDrug
  • DexamethasoneDrug

Arms8

  • Experimental

    Sedentary young adults, SMCP

    Spironolactone, Then Mifepristone, Then Combined, Then Placebo (SMCP), Then Dexamethasone

  • Experimental

    Endurance-trained young athletes, SMCP

    Spironolactone, Then Mifepristone, Then Combined, Then Placebo (SMCP), Then Dexamethasone

  • Experimental

    Sedentary young adults, MSPC

    Mifepristone, Then Spironolactone, Then Placebo, Then Combined (MSPC), Then Dexamethasone

  • Experimental

    Endurance-trained young athletes, MSPC

    Mifepristone, Then Spironolactone, Then Placebo, Then Combined (MSPC), Then Dexamethasone

  • Experimental

    Sedentary young adults, CPSM

    Combined, Then Placebo, Then Spironolactone, Then Mifepristone (CPSM), Then Dexamethasone

  • Experimental

    Endurance-trained young athletes, CPSM

    Combined, Then Placebo, Then Spironolactone, Then Mifepristone (CPSM), Then Dexamethasone

  • Experimental

    Sedentary young adults,PCMS

    Placebo, Then Combined, Then Mifepristone, Then Spironolactone (PCMS), Then Dexamethasone

  • Experimental

    Endurance-trained young athletes,PCMS

    Placebo, Then Combined, Then Mifepristone, Then Spironolactone (PCMS), Then Dexamethasone

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Proportion of Suppressors After Dexamethasone

    Time frame · cortisol measured between 8 and 9 after dexamethasone was taken between 11 PM and midnight

    Registry description

    All subjects will take 0.25mg dexamethasone as an outpatient between 2300 and 2400h and will then report to the clinic by 0800h next day for the final visit. At the final visit, cortisol response to dexamethasone suppression was assessed. The cortisol response was dichotomized (suppression vs. non-suppression, using 1.8 ug/dL as the cutoff point) and compared between the two groups,Sedentary Young Adults and Endurance-trained Young Athletes.

Secondary outcomes(1)

  1. Post-dexamethasone Cortisol Level

    Time frame · Cortisol obtained at 8-9 AM after dexamethasone taken between 11 pm and midnight

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· cortisol measured between 8 and 9 after dexamethasone was taken between 11 PM and midnight

Proportion of Suppressors After Dexamethasone

GroupValue (Participants)
Endurance-trained Young Athletes0
Sedentary Young Adults1
Secondary and other outcome results(1)
Secondary outcomeMean· Cortisol obtained at 8-9 AM after dexamethasone taken between 11 pm and midnight

Post-dexamethasone Cortisol Level

GroupValue (mcg/dL)Spread
Endurance-trained Young Athletes11.985.92
Sedentary Young Adults9.985.39

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Sedentary Young AdultsSedentary young adults group consists of 19 subjects, each subject was randomized to one of the following four arms: Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone0 / 190 / 190 / 19
AtheletesEndurance-trained Young Athletes group consists of 20 subjects, each subject was randomized to one of the following four arms: Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone0 / 200 / 200 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
* INCLUSION CRITERIA: Men aged 18 to 30 years of age are required for the young endurance trained and sedentary groups; men aged 65-80 years for the older study group, who will meet criteria for sedentary men below. Women and children are excluded to enhance homogeneity of responses and avoid the influence of menstrual cyclicity on the HPA axis. 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: For all participants: * 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

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