A Prospective Study of Outcome After Therapy for Acromegaly

  • STATUS
    Recruiting
  • End date
    Jun 21, 2022
  • participants needed
    250
  • sponsor
    Columbia University
Updated on 21 July 2021
medical therapy
somatomedin c
growth hormone
hepatic disease
tolerance test
growth factor
oral glucose tolerance test

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.

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.

Details
Condition Acromegaly
Treatment Surgery for acromegaly, Medications for acromegaly, Adipose Tissue Biopsy, Total body magnetic resonance imaging
Clinical Study IdentifierNCT01809808
SponsorColumbia University
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

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
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