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
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Condition or disease | Intervention/treatment |
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Acromegaly | Procedure: Surgery for acromegaly Drug: Medications for acromegaly Diagnostic Test: Total body magnetic resonance imaging Procedure: Adipose Tissue Biopsy |
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 |
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.
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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.
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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.
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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.
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- 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.
- 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
Biospecimen Retention: Samples Without DNA

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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 |
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.

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
Contact: Pamela U Freda, M.D. | 212-305-2254 | puf1@cumc.columbia.edu |
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. |
Principal Investigator: | Pamela U Freda, M.D. | Columbia University |
Additional Information:
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 |