Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are reduced, and likely contributes to the wasting. As TT in relatively safe physiologic replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we hypothesize that physiologic TT replacement will be effective in preventing and treating the loss of muscle mass and function in CKD patients, will improve quality of life and may reduce some cardiovascular disease (CVD) risk factors.
All subjects will undergo baseline testing that will consist of functional capacity tests, blood tests and muscle biopsies (described in detail below). Subjects will then receive testosterone gel which will be applied daily to the skin of the abdomen or thighs every morning at the same time for 16 weeks. Two days after the hormone treatment is started, the blood testosterone (TT) level will be measured 6 hours after administration. Our goal will be the attainment of serum total TT levels in the mid- to upper normal young adult range. If the serum TT is not at goal, the dose of gel will be increased or decreased repeat testing will be performed within one week. All subjects will be tested for serum TT levels every 4 weeks to assure that the serum total TT remains at goal level. Measurements will be repeated at 8 and 16 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Subjects apply contents of gel packet (Testim, 1% testosterone gel) to skin daily.
VA Palo Alto Health Care System
Palo Alto, California, United States
Santa Clara Valley Medical Center
San Jose, California, United States
Thigh Cross Sectional Area
DEXA-determined thigh cross-sectional area
Time frame: Baseline
Lean Body Mass
DEXA-determined lean body mass
Time frame: Baseline
Fat Mass
DEXA-determined total body fat mass
Time frame: Baseline
Quadriceps Strength
Lower body strength (in lbs) using quadriceps leg extension.
Time frame: Baseline
Kidney Disease-Specific Quality of Life
Questionnaire - SF-36, which stands for the Short Form 36 Health Survey. It is a widely used standardized 36 item quality of life assessment. This particular measure focused on symptoms, and is scaled from zero to 100, with a higher score indicating better health functioning.
Time frame: Baseline
Inflammatory Markers
C-Reactive Protein (CRP). CRP is measured in mg/l and is a marker of inflammation. CRP generally ranges from \<1.0 to 5 mg/L. A normal value is less than 2.0 mg/L.
Time frame: pre treatment and monthly until end of treatment
Muscle Atrophy Signaling Pathways
These include muscle growth regulatory factors, IGF-1 and myostatin, their receptors and components of the ubiquitin-proteasome and calpain proteolytic pathways and inflammatory cytokines.
Time frame: Baseline
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