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A Prospective Study of Outcome After Therapy for Acromegaly

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ClinicalTrials.gov Identifier: NCT01809808
Recruitment Status : Recruiting
First Posted : March 13, 2013
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Acromegaly Procedure: Surgery for acromegaly Drug: Medications for acromegaly Diagnostic Test: Total body magnetic resonance imaging Procedure: Adipose Tissue Biopsy

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 Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Outcome After Therapy for Acromegaly
Study Start Date : September 2003
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Acromegaly Subjects
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.
 Procedure: Surgery for acromegaly
(non-experimental) standard procedure
Drug: Medications for acromegaly
(non-experimental) standard procedure
Other Name: Drugs used to lower growth hormone
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.
Healthy Subjects
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Biochemical activity of Acromegaly [ Time Frame: At 5 years after therapy for acromegaly ]
    The study will assess the status of biochemical disease activity of acromegaly before and after treatment for acromegaly. Blood samples are taken for fasting growth hormone and insulin-like growth factor 1 and growth hormone levels 60, 90 and 120 minutes after oral glucose taken at baseline visit, post-operative or after the initiation of medical therapy at month 1 (fasting blood only), month 3 (fasting blood only), month 6, month 12, and annual assessments for at least 5 years.


Secondary Outcome Measures :
  1. Visceral Adipose Tissue Mass [ Time Frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy. ]
    Total Body Magnetic Resonance Imaging

  2. Intra-hepatic Lipid [ Time Frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy. ]
    Proton magnetic resonance spectroscopy of liver

  3. Resting metabolic rate [ Time Frame: Before, 1 year and 2 years after the intervention ]
    Measurement of resting metabolic rate by indirect calorimetry

  4. Intra-myocellular lipid [ Time Frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy. ]
    Proton magnetic resonance spectroscopy of soleus muscle

  5. Relative expression of CD11c gene [ Time Frame: Before, 1 year and 2 years after the intervention ]
    Relative expression of CD11c gene in biopsied subcutaneous adipose tissue

  6. Relative expression of CD68 gene [ Time Frame: Before, 1 year and 2 years after the intervention ]
    Relative expression of CD68 gene in biopsied subcutaneous adipose tissue

  7. Relative expression of MCP1 gene [ Time Frame: Before, 1 year and 2 years after the intervention ]
    Relative expression of MCP1 gene in biopsied subcutaneous adipose tissue

  8. Relative expression of IL6 gene [ Time Frame: Before, 1 year and 2 years after the intervention ]
    Relative expression of IL6 gene in biopsied subcutaneous adipose tissue

  9. Plasma levels of c-reactive protein [ Time Frame: Before, 1 year and 2 years after the intervention ]
    Levels of c-reactive protein in peripheral venous blood


Biospecimen Retention:   Samples Without DNA
Serum and blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.
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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809808


Contacts
Contact: Pamela U Freda, M.D. 212-305-2254 puf1@cumc.columbia.edu

Locations
United States, New York
Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970 Recruiting
New York, New York, United States, 10032
Contact: Carlos Reyes-Vidal, MD    212-305-4921      
Contact: Krystal Hernandez, MD    212-305-4921      
Principal Investigator: Pamela U Freda, M.D.         
Sponsors and Collaborators
Columbia University
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Pamela U Freda, M.D. Columbia University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Columbia University Medical Center: Neuroendocrine Diseases Program  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pamela U. Freda, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01809808     History of Changes
Other Study ID Numbers: AAAA0890
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pamela U. Freda, Columbia University:
Acromegaly
Pituitary tumor

Additional relevant MeSH terms:
Pituitary Diseases
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases