Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process. The investigators will assess the practical question of whether testosterone injection and gel application elicit similar responses. Resistance exercise will be used as a means of stimulating both inflammatory and anabolic responses in skeletal muscle. In order to assess the effects of testosterone on these responses, subjects will perform resistance exercise on two occasions separated by 7 days. The first session will be performed prior to the initiation of testosterone and/or medrol therapy and the second session will be performed after receiving therapy for 7 days.
4 groups of healthy men aged 60 - 85 years were studied over 15 days, in 2 distinct time periods, pre-treatment and treatment. Pre treatment week from study day -7 to study day -1. Treatment week from study day 1 to study day 8. Groups: 1. Testosterone by injection (100mg testosterone enanthate) administered on study day 1. 2. Testosterone by gel application (10g/day Androgel 1%) administered daily beginning on study day 1 through study day 7. 3. Methylpredisone (Medrol) dose pack beginning on study day 1 (24mg) and decreasing by 4mg each day, with an additional 4mg taken on study day 7. Study day 1 (24mg), study day 2 (20mg), study day 3 (16mg), study day 4 (12mg), study day 5 (8mg), study day 6 (4mg), study day 7 (4mg). 4. Testosterone by injection (100mg testosterone enanthate) administered on study day 1 and Methylpredisone (Medrol) dose pack beginning on study day 1 (24mg) and decreasing by 4mg each day, with an additional 4mg taken on study day 7. Study day 1 (24mg), study day 2 (20mg), study day 3 (16mg), study day 4 (12mg), study day 5 (8mg), study day 6 (4mg), study day 7 (4mg). Subjects were asked to fill out the Brief Fatigue Inventory daily for all 15 days. Subjects were studied at the clinical research center before treatment (study day 1) and after treatment (study day 8). Resistance exercise was performed on study days 1 and 8. Blood was drawn before and after exercise for measurement of serum cortisol. Subjects were asked to return to the clinical research center each day during the treatment week (study days 1-8) for blood draws for measurement of total testosterone, estradiol and C-reactive protein (CRP). Labs were drawn on study days 1 and 8 for complete blood count, comprehensive metabolic panel and lipid panel. Part 1: In this part of the project we will study the acute response to testosterone treatment between two groups of subjects, comparing two methods of administration (injection vs. topical gel) in order to obtain pilot information for a subsequent, randomized, blinded long-term investigation. Part 2: In this part of the project we will study the acute response to Medrol (methylprednisolone) taken over 7 days with or without testosterone (given as 100mg IM) in order to obtain pilot information for a subsequent, randomized, blinded long-term investigation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
100 mg single IM injection
Testosterone gel 10 mg. administered topically daily for seven days
Medrol 6 day dose pack with an additional 4mg dose on day 7
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Time frame: treatment day 1
Serum Total Testosterone Measured on Treatment Day 2
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Time frame: treatment day 2
Serum Total Testosterone Measured on Treatment Day 3
TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Time frame: treatment day 3
Serum Total Testosterone Measured on Treatment Day 4
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Time frame: treatment day 4
Serum Total Testosterone Measured on Treatment Day 5
TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Time frame: treatment day 5
Serum Total Testosterone Measured on Treatment Day 6
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Time frame: treatment day 6
Serum Total Testosterone Measured on Treatment Day 7
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Time frame: treatment day 7
Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration.
Time frame: treatment day 8
Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.
Time frame: treatment day 1
Serum Estradiol Measured on Treatment Day 8 (Post Study)
Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL.
Time frame: treatment day 8
Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.
Time frame: treatment day 1
Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL.
Time frame: treatment day 8
Hematocrit Measured on Treatment Day 1 (Baseline Study)
Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.
Time frame: treatment day 1
Hematocrit Measured on Treatment Day 8 (Post Study)
Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%.
Time frame: treatment day 8
Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.
Time frame: treatment day 1
Total Cholesterol Measured on Treatment Day 8 (Post Study)
Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL.
Time frame: treatment day 8
Triglycerides Measured on Treatment Day 1 (Baseline Study)
Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.
Time frame: treatment day 1
Triglycerides Measured on Treatment Day 8 (Post Study)
Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL.
Time frame: treatment day 8
High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.
Time frame: treatment day 1
High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL.
Time frame: treatment day 8
Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.
Time frame: treatment day 1
Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL.
Time frame: treatment day 8
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.
Time frame: treatment day 1
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL.
Time frame: treatment day 8
C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.
Time frame: treatment day 1
C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL.
Time frame: treatment day 8
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.
Time frame: treatment day 1
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL.
Time frame: treatment day 8
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.
Time frame: treatment day 1
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L.
Time frame: treatment day 8
Insulin Measured on Treatment Day 1 (Baseline Study)
Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.
Time frame: treatment day 1
Insulin Measured on Treatment Day 8 (Post Study)
Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL.
Time frame: treatment day 8
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.
Time frame: treatment day 1
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL.
Time frame: treatment day 8
Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Time frame: treatment day 1 - before exercise
Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Time frame: treatment day 1 - after exercise
Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Time frame: treatment day 8 - before exercise
Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL.
Time frame: treatment day 8 - after exercise
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. This data is presented as the pre-treatment week average of study days -7 to -1.
Time frame: Study days -7 to -1 (Pre - treatment)
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. This data is presented as the treatment week average of study days 1-8.
Time frame: Study days 1-7 (treatment week)
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