NCT01809808

A Prospective Study of Outcome After Therapy for Acromegaly

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 280 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Acromegaly

Interventions

Type	Name	Description
PROCEDURE	Surgery for acromegaly	(non-experimental) standard procedure
DRUG	Medications for acromegaly	(non-experimental) standard procedure
DIAGNOSTIC_TEST	Total body magnetic resonance imaging	Subjects will undergo total body MRI with spectroscopy of the muscle and liver before and 3-6 months, 12 and 24 months after surgery or medical therapy for acromegaly.
PROCEDURE	Adipose Tissue Biopsy	Subjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly.

Timeline

• Start date: 2003-09-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2013-03-13
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States