Lifestyle Intervention and Testosterone Replacement in Obese Seniors
Condition: Obesity and Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone; Lifestyle Therapy; Placebo
Intervention description: Daily testosterone gel applied once daily in the morning to intact skin; Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week; Placebo gel for testosterone
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 83.0
Sex: Male
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Obesity; Hypogonadism; Frailty

Summary:

      The prevalence of obesity in Veterans is greater than in the general population, and even
      more so among users of the VA Health Care System. In addition, the population of obese older
      Veterans is rapidly increasing as more baby boomers become senior citizens. In older
      Veterans, obesity exacerbates the age- related decline in physical function and causes
      frailty which predisposes to admission to a VA chronic care facility. However, the optimal
      clinical approach to obesity in older adults is controversial because of the concern that
      weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and
      bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any
      guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of
      testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and
      reverse frailty in obese older Veterans and thus prevent their loss of independence and
      decrease demand for VA health care services.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects will be

          -  older (65-85 yr)

          -  obese (BMI 30 kg/m2 or greater) Veteran men with low testosterone (less than 300
             mg/dL) as defined by the Endocrine Society

          -  mild to moderately frail

          -  must have stable weight (~not less than or more than 2 kg) during the last 6 months

          -  sedentary (regular exercise less than 1 h/week or less than 2x/week for the last 6
             months)

        Exclusion Criteria:

          -  Any major chronic diseases, or any condition that would interfere with exercise or
             dietary restriction, in which exercise or dietary restriction are contraindicated, or
             that would interfere with interpretation of results.

          -  Examples include, but are not limited to:

               -  cardiopulmonary disease (e.g. recent myocardial infarction (MI), unstable angina,
                  stroke etc) or unstable disease (e.g. CHF)

               -  severe orthopedic/musculoskeletal or neuromuscular impairments

               -  visual or hearing impairments

               -  cognitive impairment (Mini Mental State Exam Score less than 24)

               -  current use of bone active drugs

               -  uncontrolled diabetes (i.e. fasting blood glucose more than 140 mg/dl and/or
                  HbA1c greater than 9.5%).

          -  Any contraindications to testosterone supplementation

               -  history of prostate or breast cancer

               -  history of testicular disease

               -  untreated sleep apnea

               -  hematocrit more than 50%

               -  prostate-related findings of palpable nodule on exam, a serum PSA of 4.0 ng/ml or
                  greater

               -  International Prostate Symptom Sore more than 19

               -  history of venous thromboembolism

          -  Osteoporosis or a BMD T-score of -2.5 in the lumbar spine or total hip as well as
             those patients with a history of osteoporosis-related fracture (spine, hip, or wrist)