Lead Investigator: Odelia Cooper, Cedars-Sinai Medical Center
Title of Proposal Research: A study of how growth hormone treatment affects health outcomes in patients with noncancerous craniopharyngioma tumors
Vivli Data Request: 6532
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Craniopharyngioma (CP) is a rare type of tumor that grows near the pituitary gland at the base of the brain. It is estimated that 400 people are diagnosed with this condition in the United States each year. Patients with these tumors are often unable to control their appetites. They gain a lot of weight and develop diseases related to extreme weight gain that make them ill. Some patients have diabetes mellitus, some have fatty liver disease, and some have heart disease. If these diseases are not treated early, they can shorten a person’s lifespan.
Approximately 80% of adults with craniopharyngioma produce too little growth hormone from the pituitary gland. This likely occurs because the tumor presses against the pituitary gland. We believe that treating these patients with growth hormone will prevent or improve outcomes from the diseases caused by the extreme weight gain.
The Hypopituitary Control and Complications Study (HypoCSS) contains information on 9,686 adults from around the world who have too little growth hormone. This includes 956 patients with craniopharyngioma who were treated with growth hormone and 102 patients with craniopharyngioma who were not treated with growth hormone.
We plan to study health outcomes in these patients. We will look at how growth hormone treatment affects weight gain and development of fatty liver disease, diabetes mellitus, and heart disease in patients with craniopharyngioma. We will also look at how growth hormone treatment affects development of these same diseases in patients who do not have craniopharyngioma.
We believe this study will provide important information needed to determine whether patients with craniopharyngioma should be treated with growth hormone.
The Global Hypopituitary Control and Complications Study
Sponsor: Eli Lilly and Company
Study ID: NCT01088399
Sponsor ID: 6448