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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 : July 13, 2021
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University

Tracking Information
First Submitted Date August 8, 2012
First Posted Date March 13, 2013
Last Update Posted Date July 13, 2021
Actual Study Start Date September 2003
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 10, 2018)
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.
Original Primary Outcome Measures
 (submitted: March 11, 2013)
Assessment of 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 month 1(fasting blood only), post-operative month 3(fasting blood only), post-operative month 6, post-operative month 12, and annual assessments for at least 5 years.
Change History
Current Secondary Outcome Measures
 (submitted: April 29, 2019)
  • 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
  • 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
  • Resting metabolic rate [ Time Frame: Before, 1 year and 2 years after the intervention ]
    Measurement of resting metabolic rate by indirect calorimetry
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Plasma Levels of ghrelin [ Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention ]
    Levels of ghrelin in peripheral blood
  • Plasma Levels of AgRP [ Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention ]
    Levels of AgRP in peripheral blood
  • Plasma Levels of GLP1 [ Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention ]
    Levels of GLP1 in peripheral blood
  • Serum Levels of insulin [ Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention ]
    Levels of insulin in peripheral blood
  • Serum Levels of glucose [ Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention ]
    Levels of glucose in peripheral blood
  • Serum Levels of glucagon [ Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention ]
    Levels of glucagon in peripheral blood
  • Serum Levels of GIP [ Time Frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention ]
    Levels of GIP in peripheral blood
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum and blood samples
Sampling Method Non-Probability Sample
Study Population Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.
Condition Acromegaly
Intervention
  • 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.
Study Groups/Cohorts
  • 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.
    Interventions:
    • Procedure: Surgery for acromegaly
    • Drug: Medications for acromegaly
    • Diagnostic Test: Total body magnetic resonance imaging
    • Procedure: Adipose Tissue Biopsy
  • 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.
    Interventions:
    • Diagnostic Test: Total body magnetic resonance imaging
    • Procedure: Adipose Tissue Biopsy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 11, 2013)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Pamela U Freda, M.D. 212-305-2254 puf1@cumc.columbia.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01809808
Other Study ID Numbers AAAA0890
R56DK064720 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Pamela U. Freda, Columbia University
Study Sponsor Columbia University
Collaborators
  • Icahn School of Medicine at Mount Sinai
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Pamela U Freda, M.D. Columbia University
PRS Account Columbia University
Verification Date July 2021