Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Testosterone injection; Testosterone gel; Medrol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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
Other intervention name(s): Testosterone enanthate; Androgel 1%; methylprednisolone; Medrol dose pack
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Methyltestosterone; Prednisolone hemisuccinate; Prednisolone phosphate; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sarcopenia; Aging muscle; Androgen; Cytokines; Muscle metabolism