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Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men

Primary Purpose

Sarcopenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Testosterone injection
Testosterone gel
Medrol
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia, Aging muscle, Androgen, Cytokines, Muscle metabolism

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 60-85
  • Gender: Male

Exclusion Criteria:

  • Exclusionary medications will be an anticoagulant (Coumadin) because of the risk of bleeding during the biopsy procedure. Additional medications which will be disallowed for participation include: anabolic steroids, nitrates, antihistamines, and glucocorticoids.
  • The subjects must be able to successfully complete an exercise stress test using the Bruce protocol . Subjects will be excluded without exercise testing, with a history of angina that occurs with exertion or at rest, or a myocardial infarction within the last 12 months. Subjects that demonstrate ³0.1 milliVolts (mV) horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ³10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ³10 premature ventricular contractions (PVC)/min, or couplets) during the stress test will be excluded.
  • Subjects with LDL cholesterol above 200 mg/dL will be excluded .
  • Any man with a history of breast cancer or prostate cancer, or any indication of an occult carcinoma from an elevation of prostate specific antigen (PSA) above 4.0 mg/L (53), or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream) will be excluded.
  • Subjects with liver dysfunction evidenced by a history of hepatitis B or hepatitis C, or by a three-fold elevation of liver enzymes (Alk phos, alanine aminotransferase (ALT), aspartate amino-transferase (AST) above normal on screening will be excluded from the study.
  • Any subject with a blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ³ 140 or a diastolic blood pressure ³ 90 will be excluded.
  • Any subject who has a major medical illness such as diabetes, chronic obstructive pulmonary disease, or sleep apnea will be excluded. Moreover, subjects will not have a recent history of smoking tobacco. Morbidly obese older men (BMI > 35) will also be excluded.
  • Subjects will evidence of kidney disease (serum creatinine > 2.0mg/dl) will be excluded from participation.
  • Any subject with thyroid disease as determined by an abnormal thyroid stimulating hormone (TSH) level will be excluded from participation.
  • Any subject testing positive for HIV will be excluded .
  • Allergy to iodine, a component of Betadine which is used to prepare the subject's skin for invasive procedures, will be cause for exclusion from this study.
  • Men with serum total testosterone concentrations greater than 500 ng/dL will be excluded.
  • Subjects who engage in high intensity resistance training on a regular basis will be excluded.
  • Subjects with a known coagulation disorder or with clinical evidence indicative of a bleeding disorder (easy bruising, "free bleeders") will not be enrolled in this study due to potential problems that could arise from muscle biopsy procedures.

Sites / Locations

  • The University of Texas Medical Branch at Galveston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Testosterone injection

Testosterone gel

Testosterone injection and Medrol 6 day dose pack

Medrol 6 day dose pack

Arm Description

Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection

Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days

Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.

Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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%.
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%.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2009
Last Updated
April 4, 2018
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT00957801
Brief Title
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
Official Title
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: Testosterone by injection (100mg testosterone enanthate) administered on study day 1. Testosterone by gel application (10g/day Androgel 1%) administered daily beginning on study day 1 through study day 7. 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Aging muscle, Androgen, Cytokines, Muscle metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone injection
Arm Type
Active Comparator
Arm Description
Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection
Arm Title
Testosterone gel
Arm Type
Active Comparator
Arm Description
Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days
Arm Title
Testosterone injection and Medrol 6 day dose pack
Arm Type
Active Comparator
Arm Description
Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.
Arm Title
Medrol 6 day dose pack
Arm Type
Active Comparator
Arm Description
Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg.
Intervention Type
Drug
Intervention Name(s)
Testosterone injection
Other Intervention Name(s)
Testosterone enanthate
Intervention Description
100 mg single IM injection
Intervention Type
Drug
Intervention Name(s)
Testosterone gel
Other Intervention Name(s)
Androgel 1%
Intervention Description
Testosterone gel 10 mg. administered topically daily for seven days
Intervention Type
Drug
Intervention Name(s)
Medrol
Other Intervention Name(s)
methylprednisolone, Medrol dose pack
Intervention Description
Medrol 6 day dose pack with an additional 4mg dose on day 7
Primary Outcome Measure Information:
Title
Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
Description
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
Title
Serum Total Testosterone Measured on Treatment Day 2
Description
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
Title
Serum Total Testosterone Measured on Treatment Day 3
Description
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
Title
Serum Total Testosterone Measured on Treatment Day 4
Description
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
Title
Serum Total Testosterone Measured on Treatment Day 5
Description
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
Title
Serum Total Testosterone Measured on Treatment Day 6
Description
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
Title
Serum Total Testosterone Measured on Treatment Day 7
Description
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
Title
Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
Description
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
Title
Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Serum Estradiol Measured on Treatment Day 8 (Post Study)
Description
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
Title
Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
Description
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
Title
Hematocrit Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Hematocrit Measured on Treatment Day 8 (Post Study)
Description
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
Title
Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Total Cholesterol Measured on Treatment Day 8 (Post Study)
Description
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
Title
Triglycerides Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Triglycerides Measured on Treatment Day 8 (Post Study)
Description
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
Title
High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
Description
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
Title
Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
Description
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
Title
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
Description
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
Title
C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
Description
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
Title
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
Description
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
Title
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
Description
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
Title
Insulin Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Insulin Measured on Treatment Day 8 (Post Study)
Description
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
Title
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
Description
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
Title
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
Description
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
Title
Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
Description
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
Title
Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
Description
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
Title
Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
Description
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
Title
Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
Description
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
Title
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
Description
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)
Title
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
Description
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)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 60-85 Gender: Male Exclusion Criteria: Exclusionary medications will be an anticoagulant (Coumadin) because of the risk of bleeding during the biopsy procedure. Additional medications which will be disallowed for participation include: anabolic steroids, nitrates, antihistamines, and glucocorticoids. The subjects must be able to successfully complete an exercise stress test using the Bruce protocol . Subjects will be excluded without exercise testing, with a history of angina that occurs with exertion or at rest, or a myocardial infarction within the last 12 months. Subjects that demonstrate ³0.1 milliVolts (mV) horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ³10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ³10 premature ventricular contractions (PVC)/min, or couplets) during the stress test will be excluded. Subjects with LDL cholesterol above 200 mg/dL will be excluded . Any man with a history of breast cancer or prostate cancer, or any indication of an occult carcinoma from an elevation of prostate specific antigen (PSA) above 4.0 mg/L (53), or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream) will be excluded. Subjects with liver dysfunction evidenced by a history of hepatitis B or hepatitis C, or by a three-fold elevation of liver enzymes (Alk phos, alanine aminotransferase (ALT), aspartate amino-transferase (AST) above normal on screening will be excluded from the study. Any subject with a blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ³ 140 or a diastolic blood pressure ³ 90 will be excluded. Any subject who has a major medical illness such as diabetes, chronic obstructive pulmonary disease, or sleep apnea will be excluded. Moreover, subjects will not have a recent history of smoking tobacco. Morbidly obese older men (BMI > 35) will also be excluded. Subjects will evidence of kidney disease (serum creatinine > 2.0mg/dl) will be excluded from participation. Any subject with thyroid disease as determined by an abnormal thyroid stimulating hormone (TSH) level will be excluded from participation. Any subject testing positive for HIV will be excluded . Allergy to iodine, a component of Betadine which is used to prepare the subject's skin for invasive procedures, will be cause for exclusion from this study. Men with serum total testosterone concentrations greater than 500 ng/dL will be excluded. Subjects who engage in high intensity resistance training on a regular basis will be excluded. Subjects with a known coagulation disorder or with clinical evidence indicative of a bleeding disorder (easy bruising, "free bleeders") will not be enrolled in this study due to potential problems that could arise from muscle biopsy procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall J Urban, M.D.
Organizational Affiliation
The University of Texas Medical Branch at Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0567
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men

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