Brief Title
A Prospective Study of Outcome After Therapy for Acromegaly
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 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.
Study Type
Observational
Primary Outcome
Biochemical activity of Acromegaly
Secondary Outcome
Visceral Adipose Tissue Mass
Condition
Acromegaly
Intervention
Surgery for acromegaly
Study Arms / Comparison 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
250
Start Date
September 2003
Completion Date
June 2022
Primary Completion Date
June 2022
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Pamela U Freda, M.D., 212-305-2254, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01809808
Organization ID
AAAA0890
Secondary IDs
R56DK064720
Responsible Party
Principal Investigator
Study Sponsor
Columbia University
Collaborators
Icahn School of Medicine at Mount Sinai
Study Sponsor
Pamela U Freda, M.D., Principal Investigator, Columbia University
Verification Date
July 2021