Trial Outcomes & Findings for Evaluation of Cortisol Resistance in Young Sedentary and Endurance-Trained Men (NCT NCT01294319)

Last Updated: 2024-07-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

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

Results posted on

2024-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Sedentary Young Adults, SMCP Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone	Endurance-trained Young Athletes, SMCP Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone	Sedentary Young Adults, MSPC Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone	Endurance-trained Young Athletes, MSPC Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone	Sedentary Young Adults, CPSM Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone	Endurance-trained Young Athletes, CPSM Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone	Sedentary Young Adults,PCMS Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone	Endurance-trained Young Athletes,PCMS Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
Overall Study STARTED	4	6	5	5	5	4	5	5
Overall Study COMPLETED	4	6	5	5	5	4	5	5
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sedentary Young Adults, SMCP n=4 Participants Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone	Endurance-trained Young Athletes, SMCP n=6 Participants Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone	Sedentary Young Adults, MSPC n=5 Participants Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone	Endurance-trained Young Athletes, MSPC n=5 Participants Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone	Sedentary Young Adults, CPSM n=5 Participants Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone	Endurance-trained Young Athletes, CPSM n=4 Participants Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone	Sedentary Young Adults,PCMS n=5 Participants Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone	Endurance-trained Young Athletes,PCMS n=5 Participants Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone	Total n=39 Participants Total of all reporting groups
Age, Continuous	23.57 years STANDARD_DEVIATION 0.99 • n=39 Participants	25.01 years STANDARD_DEVIATION 1.58 • n=41 Participants	24.2 years STANDARD_DEVIATION 2.33 • n=35 Participants	25.2 years STANDARD_DEVIATION 1.79 • n=31 Participants	23.3 years STANDARD_DEVIATION 2.97 • n=146 Participants	24.5 years STANDARD_DEVIATION 4.22 • n=19 Participants	27.8 years STANDARD_DEVIATION 3.06 • n=147 Participants	23.6 years STANDARD_DEVIATION 4.01 • n=193 Participants	24.73 years STANDARD_DEVIATION 2.87
Sex/Gender, Customized Male	4 Participants n=39 Participants	5 Participants n=41 Participants	5 Participants n=35 Participants	5 Participants n=31 Participants	4 Participants n=146 Participants	4 Participants n=19 Participants	5 Participants n=147 Participants	5 Participants n=193 Participants	37 Participants
Sex/Gender, Customized Unknown	0 Participants n=39 Participants	1 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	1 Participants n=146 Participants	0 Participants n=19 Participants	0 Participants n=147 Participants	0 Participants n=193 Participants	2 Participants
Body Mass Index	23.6 Kg/m^2 STANDARD_DEVIATION 4.33 • n=39 Participants	24.0 Kg/m^2 STANDARD_DEVIATION 3.27 • n=41 Participants	23.7 Kg/m^2 STANDARD_DEVIATION 3.04 • n=35 Participants	22.3 Kg/m^2 STANDARD_DEVIATION 1.89 • n=31 Participants	24.2 Kg/m^2 STANDARD_DEVIATION 2.75 • n=146 Participants	24.1 Kg/m^2 STANDARD_DEVIATION 1.10 • n=19 Participants	23.4 Kg/m^2 STANDARD_DEVIATION 2.98 • n=147 Participants	22.8 Kg/m^2 STANDARD_DEVIATION 2.00 • n=193 Participants	23.53 Kg/m^2 STANDARD_DEVIATION 2.63
Race Asian	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants	1 Participants n=31 Participants	0 Participants n=146 Participants	1 Participants n=19 Participants	1 Participants n=147 Participants	0 Participants n=193 Participants	7 Participants
Race Black	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	2 Participants n=146 Participants	1 Participants n=19 Participants	1 Participants n=147 Participants	0 Participants n=193 Participants	4 Participants
Race White	1 Participants n=39 Participants	3 Participants n=41 Participants	2 Participants n=35 Participants	4 Participants n=31 Participants	2 Participants n=146 Participants	2 Participants n=19 Participants	2 Participants n=147 Participants	1 Participants n=193 Participants	17 Participants
Race Unknown	2 Participants n=39 Participants	2 Participants n=41 Participants	1 Participants n=35 Participants	0 Participants n=31 Participants	1 Participants n=146 Participants	0 Participants n=19 Participants	1 Participants n=147 Participants	4 Participants n=193 Participants	11 Participants
Total Fat Percent	21.1 percent STANDARD_DEVIATION 6.90 • n=39 Participants	20.2 percent STANDARD_DEVIATION 5.16 • n=41 Participants	25.2 percent STANDARD_DEVIATION 5.11 • n=35 Participants	19.5 percent STANDARD_DEVIATION 1.99 • n=31 Participants	23.2 percent STANDARD_DEVIATION 5.82 • n=146 Participants	19.7 percent STANDARD_DEVIATION 5.15 • n=19 Participants	24.4 percent STANDARD_DEVIATION 5.16 • n=147 Participants	16.8 percent STANDARD_DEVIATION 4.04 • n=193 Participants	21.33 percent STANDARD_DEVIATION 5.28
Fat mass	16.28 kg STANDARD_DEVIATION 8.05 • n=39 Participants	16.73 kg STANDARD_DEVIATION 5.60 • n=41 Participants	19.13 kg STANDARD_DEVIATION 4.80 • n=35 Participants	14.70 kg STANDARD_DEVIATION 3.19 • n=31 Participants	19.21 kg STANDARD_DEVIATION 8.69 • n=146 Participants	15.13 kg STANDARD_DEVIATION 3.79 • n=19 Participants	17.64 kg STANDARD_DEVIATION 4.31 • n=147 Participants	13.69 kg STANDARD_DEVIATION 4.56 • n=193 Participants	16.61 kg STANDARD_DEVIATION 5.45

PRIMARY outcome

Timeframe: cortisol measured between 8 and 9 after dexamethasone was taken between 11 PM and midnight

Outcome measures

Outcome measures
Measure	Endurance-trained Young Athletes n=20 Participants Endurance-trained Young Athletes group consists of 20 subjects, each subject was randomized to one of the following four arms: 1. Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone 2. Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone 3. Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone 4. Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone	Sedentary Young Adults n=19 Participants Sedentary young adults group consists of 19 subjects, each subject was randomized to one of the following four arms: 1. Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone 2. Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone 3. Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone 4. Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
Proportion of Suppressors After Dexamethasone	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Cortisol obtained at 8-9 AM after dexamethasone taken between 11 pm and midnight

Outcome measures

Outcome measures
Measure	Endurance-trained Young Athletes n=20 Participants Endurance-trained Young Athletes group consists of 20 subjects, each subject was randomized to one of the following four arms: 1. Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone 2. Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone 3. Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone 4. Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone	Sedentary Young Adults n=19 Participants Sedentary young adults group consists of 19 subjects, each subject was randomized to one of the following four arms: 1. Spironolactone, Then Mifepristone, Then Combined, Then Placebo, Then Dexamethasone 2. Mifepristone, Then Spironolactone, Then Placebo, Then Combined, Then Dexamethasone 3. Combined, Then Placebo, Then Spironolactone, Then Mifepristone, Then Dexamethasone 4. Placebo, Then Combined, Then Mifepristone, Then Spironolactone, Then Dexamethasone
Post-dexamethasone Cortisol Level	11.98 mcg/dL Standard Deviation 5.92	9.98 mcg/dL Standard Deviation 5.39

Adverse Events

Sedentary Young Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atheletes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lynnette Nieman

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Phone: 301-496-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place