A Prospective Study of Outcome After Therapy for Acromegaly

Columbia University

Status: Completed

Conditions: Acromegaly

Treatments: Procedure: Surgery for acromegaly; Procedure: Adipose Tissue Biopsy; Diagnostic Test: Total body magnetic resonance imaging; Drug: Medications for acromegaly

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01809808

R56DK064720 (U.S. NIH Grant/Contract)

AAAA0890

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Acromegaly Subjects

Inclusion Criteria:

• Adult males and females.
• Ages 18 and over.
• Presenting to the PI or one of the sub-investigators for evaluation of acromegaly.
• Must have a biochemical diagnosis of acromegaly consisting of an elevated serum insulin-like growth factor 1 (IGF-1) level. Supportive although not required for entry are an elevated growth hormone (GH) level and a failure of GH to suppress normally after oral glucose administration.
• Willingness to participate in this study's procedures.

Exclusion Criteria:

• Subjects who are unwilling to comply with the procedures outlined in the study.
• Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures
• Are unwilling to provide informed consent to participate in the study.

Healthy Subjects

Inclusion Criteria:

• Adult males and females.
• Ages 18 and over.
• Responding to ads for participation or by word of mount.
• No medical problems, no medications, stable weight for 3 months prior to study.
• Willingness to participate in this study's procedures.

Exclusion Criteria:

• Subjects who are unwilling to comply with the procedures outlined in the study.
• Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures
• Are unwilling to provide informed consent to participate in the study.
• Failure to meet the inclusion criteria.

Trial design

280 participants in 2 patient groups

Acromegaly Subjects

Description:

People who have a biochemical diagnosis of acromegaly, and will or have already undergone surgery for acromegaly and will be taking medications for acromegaly . Subjects will undergo blood sampling, metabolic rate measurement, adipose tissue biopsy and total body magnetic resonance imaging before and over time after either surgery or medical therapy for acromegaly.

Treatment:

Drug: Medications for acromegaly

Diagnostic Test: Total body magnetic resonance imaging

Procedure: Adipose Tissue Biopsy

Procedure: Surgery for acromegaly

Healthy Subjects

Description:

People who are not diagnosed with acromegaly, responding to flyer or by word of mouth for participation, without medical problems, not taking medications, and with a stable weight for 3 months prior to study. Subjects will undergo blood sampling, total body MRI and adipose tissue biopsy once.

Treatment:

Diagnostic Test: Total body magnetic resonance imaging

Procedure: Adipose Tissue Biopsy