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NCT Number: NCT01809808

A Prospective Study of Outcome After Therapy for Acromegaly

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery for acromegaly

Procedure

(non-experimental) standard procedure

Medications for acromegaly

Drug

(non-experimental) standard procedure

Other names: Drugs used to lower growth hormone

Total body magnetic resonance imaging

Diagnostic Test

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.

Adipose tissue biopsy

Procedure

Subjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly.

Primary outcomes

  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 outcomes

  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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2003
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2013
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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