Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency
Condition: Hypopituitarism
MeSH terms: Hypopituitarism
Intervention: Human Growth Hormone (1-134); Placebo
Intervention description: Subjects randomized to human growth hormone (1-134) for 16 weeks. In this arm, growth hormone is dosed sc on a daily basis and increased over first 6 weeks (Men: start at 0.2 mg sc/d, increase to 0.6 mg sc/d after 4 weeks. Women, postmenopausal: start at 0.3 mg sc/d, increase to 0.9 mg sc/d after 4 weeks. Women premenopausal or on estrogen: start at 0.6 mg sc/d, increase to 1.3 mg sc/d after 4 weeks.) Dose adjustments based on serum IGF-1 levels at 6 and 12 weeks, with final IGF-1 measurement for efficacy performed at 16 weeks, with goal in range of -0.5 SD to +2SD. An elevated serum IGF-1 value will result in a 20% dose reduction in GH in an active and random placebo patient. Similarly, a low serum IGF-1 will result in a 20% dose increase in an active and random placebo subject.; Subjects randomized to placebo
Intervention MeSH terms: Hormones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Patients with Growth hormone (GH) deficiency often report impaired quality of life and
      difficulty with mental functioning. It has been suggested that GH replacement in such
      patients leads to improvement in cognitive function. The aim of this study is to elucidate
      the effects of GH replacement in patients with GH deficiency on cognitive function using
      structural and functional neuroimaging and cognitive testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age 18-65 years old

          -  Both men and women

          -  Naive to GH replacement therapy

          -  Diagnosis of Growth Hormone deficiency, adult onset

          -  Good general health

          -  Normal thyroid, adrenal or gonadal function, or stable thyroid, glucocorticoid (at
             replacement doses) and gonadal replacement therapy for at least 3 months prior to
             study initiation. If subjects are receiving transdermal testosterone, attainment of
             mid-normal serum values will be considered adequate. If subjects are on intramuscular
             testosterone, attainment of mid-normal serum testosterone at mid-injection cycle will
             be considered adequate

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) prior to enrollment in the study

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if Growth Hormone therapy was initiated

          -  Idiopathic Growth Hormone Deficiency

          -  DSM IV diagnosis of Major Depressive Disorder with or without psychotic features,
             Bipolar II Disorder with or without psychotic features in a major depressive episode

          -  Current use of psychotropic medications

          -  History of moderate to severe brain injury

          -  Clinically significant cardiovascular disease

          -  Anemia with hct<30

          -  Renal insufficiency with creatinine >2.0

          -  Recent history of excessive alcohol use

          -  Participation in another simultaneous medical investigation or trial

          -  Active neoplasm

          -  Prader Willi Syndrome

          -  History of brain radiation

          -  Chemotherapy, past or present use

          -  History of head or eye injury involving persistent metal fragments, and implanted
             electrical device (such as a heart pacemaker)