Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970
New York, 10032, United States
NCT Number: NCT01809808
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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Notify Me18 year and older
All sexes
Observational
New York, 10032, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Acromegaly Subjects
Inclusion criteria
Exclusion criteria
Healthy Subjects
Inclusion criteria
Exclusion criteria
(non-experimental) standard procedure
(non-experimental) standard procedure
Other names: 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.
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.
Time frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Total Body Magnetic Resonance Imaging
Time frame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
Proton magnetic resonance spectroscopy of liver
Time frame: Before, 1 year and 2 years after the intervention
Measurement of resting metabolic rate by indirect calorimetry
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
Time frame: Before, 1 year and 2 years after the intervention
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 in biopsied subcutaneous adipose tissue
Time frame: Before, 1 year and 2 years after the intervention
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 in biopsied subcutaneous adipose tissue
Time frame: Before, 1 year and 2 years after the intervention
Levels of c-reactive protein in peripheral venous blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of ghrelin in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of AgRP in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of GLP1 in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of insulin in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of glucose in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of glucagon in peripheral blood
Time frame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Levels of GIP in peripheral blood
Columbia University
Other
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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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