NCT00957801

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Male
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

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: 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.

Conditions

• Sarcopenia

Interventions

Type	Name	Description
DRUG	Testosterone injection	100 mg single IM injection
DRUG	Testosterone gel	Testosterone gel 10 mg. administered topically daily for seven days
DRUG	Medrol	Medrol 6 day dose pack with an additional 4mg dose on day 7

Timeline

• Start date: 2009-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2009-08-12
• Last updated: 2018-05-08
• Results posted: 2018-04-04

Locations

1 site across 1 country: United States