A Prospective Study of Outcome After Therapy for Acromegaly

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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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 2025

Primary Completion Date

June 2025

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., ,

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

October 2022