An observational study in Acromegaly, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Columbia University · Observational
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.
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.
202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.
This study's enrollment of 280 is above the median of 100 across 81 observational studies indexed under Acromegaly.
Browse Acromegaly studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.
Acromegaly Subjects
Inclusion Criteria:
Exclusion Criteria:
Healthy Subjects
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: Medications for acromegaly · Diagnostic Test: Total body magnetic resonance imaging · Procedure: Adipose Tissue Biopsy
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 · Procedure: Adipose Tissue Biopsy
(non-experimental) standard procedure
(non-experimental) standard procedure
Also known as: Drugs used to lower growth hormone
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.
Subjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly.
Biochemical activity of 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.
Time frame: At 5 years after therapy for acromegaly
Visceral Adipose Tissue Mass
Total Body Magnetic Resonance Imaging
Time frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Intra-hepatic Lipid
Proton magnetic resonance spectroscopy of liver
Time frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Resting metabolic rate
Measurement of resting metabolic rate by indirect calorimetry
Time frame: Before, 1 year and 2 years after the intervention
Intra-myocellular lipid
Proton magnetic resonance spectroscopy of soleus muscle
Time frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Relative expression of CD11c gene
Relative expression of CD11c gene in biopsied subcutaneous adipose tissue
Time frame: Before, 1 year and 2 years after the intervention
Relative expression of CD68 gene
Relative expression of CD68 gene in biopsied subcutaneous adipose tissue
Time frame: Before, 1 year and 2 years after the intervention
Relative expression of MCP1 gene
Relative expression of MCP1 gene in biopsied subcutaneous adipose tissue
Time frame: Before, 1 year and 2 years after the intervention
Relative expression of IL6 gene
Relative expression of IL6 gene in biopsied subcutaneous adipose tissue
Time frame: Before, 1 year and 2 years after the intervention
Plasma levels of c-reactive protein
Levels of c-reactive protein in peripheral venous blood
Time frame: Before, 1 year and 2 years after the intervention
Plasma Levels of ghrelin
Levels of ghrelin in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Plasma Levels of AgRP
Levels of AgRP in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Plasma Levels of GLP1
Levels of GLP1 in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of insulin
Levels of insulin in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of glucose
Levels of glucose in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of glucagon
Levels of glucagon in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Serum Levels of GIP
Levels of GIP in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Plan to share: Undecided
Ran from Sep 2003 to primary completion in Aug 2025, 263 months.
Of 26 observational studies under Acromegaly, half reached primary completion within 85 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 263. This study's 263 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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