Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency

• Status: Completed
• Trial end date: 2012-12-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Genentech, Inc.
• Treatments: Hormones

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)