Clinical Trial: A Prospective Study of Outcome After Therapy for Acromegaly

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: A Prospective Study of Outcome After Therapy for Acromegaly

Brief Summary: The purpose of this study is to evaluate hormone values and other markers of disease activity in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after surgical or other treatment. This study is designed to determine blood levels of growth hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of the disease at diagnosis and how these parameters change over time after surgical or other therapy. The investigators will also obtain hormonal data in a group of 50 healthy subjects who will each be studied just once with an oral glucose tolerance test (OGTT). These data will provide a comparison group to the acromegaly subjects.

Detailed Summary: Surgical removal of the pituitary tumor is the usual first form of treatment offered, but this is curative in only approximately 70% of patients. If not adequately treated, the disease can have significant morbidity largely due to the development of hypertension, diabetes and malignancy as well as possible loss of vision or other neurologic complications of a large pituitary mass. Inadequately treated acromegaly is also associated with a mortality rate 2-3 fold over the general population. All the mechanisms responsible for the increased morbidity and mortality in acromegaly as well as what biochemical criteria should be used during treatment in order to normalize the increased morbidity and mortality are not known. This study aims to follow patients with acromegaly prospectively from active disease through treatment in order to identify these factors.
Sponsor: Columbia University

Current Primary Outcome: Presence of of biochemical activity of acromegaly in subjects [ Time Frame: At 5 years after therapy for acromegaly ]

The study will assess the status of biochemical disease activity of acromegaly before and after treatment for acromegaly. Blood samples are taken for fasting growth hormone and insulin-like growth factor 1 and growth hormone levels 60, 90 and 120 minutes after oral glucose taken at baseline visit, post-operative month 1 (fasting blood only), post-operative month 3 (fasting blood only), post-operative month 6, post-operative month 12, and annual assessments for at least 5 years.


Original Primary Outcome: Assessment of biochemical activity of acromegaly. [ Time Frame: At 5 years after therapy for acromegaly. ]

The study will assess the status of biochemical disease activity of acromegaly before and after treatment for acromegaly. Blood samples are taken for fasting growth hormone and insulin-like growth factor 1 and growth hormone levels 60, 90 and 120 minutes after oral glucose.taken at baseline visit, post-operative month 1(fasting blood only), post-operative month 3(fasting blood only), post-operative month 6, post-operative month 12, and annual assessments for at least 5 years.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Columbia University

Dates:
Date Received: August 8, 2012
Date Started: September 2003
Date Completion: June 2020
Last Updated: February 2, 2017
Last Verified: February 2017