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| ID | Type | Description | Link |
|---|---|---|---|
| R56DK064720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery for acromegaly | Procedure | (non-experimental) standard procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 5 years after therapy for acromegaly |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral Adipose Tissue Mass | Total Body Magnetic Resonance Imaging | 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 |
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Acromegaly Subjects
Inclusion Criteria:
Exclusion Criteria:
Healthy Subjects
Inclusion Criteria:
Exclusion Criteria:
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Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Pamela U Freda, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970 | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31361303 | Derived | Freda PU, Reyes-Vidal C, Jin Z, Pugh M, Panigrahi SK, Bruce JN, Wardlaw SL. Plasma Agouti-Related Protein Levels in Acromegaly and Effects of Surgical or Pegvisomant Therapy. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5453-5461. doi: 10.1210/jc.2019-01079. | |
| 26037515 | Derived | Reyes-Vidal CM, Mojahed H, Shen W, Jin Z, Arias-Mendoza F, Fernandez JC, Gallagher D, Bruce JN, Post KD, Freda PU. Adipose Tissue Redistribution and Ectopic Lipid Deposition in Active Acromegaly and Effects of Surgical Treatment. J Clin Endocrinol Metab. 2015 Aug;100(8):2946-55. doi: 10.1210/jc.2015-1917. Epub 2015 Jun 2. |
| Label | URL |
|---|---|
| Columbia University Medical Center: Neuroendocrine Diseases Program | View source |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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Serum and blood samples
| Medications for acromegaly |
| Drug |
(non-experimental) standard procedure |
|
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| 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. |
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| 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. |
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| 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 | Before, 1 year and 2 years after the intervention |
| Intra-myocellular lipid | Proton magnetic resonance spectroscopy of soleus muscle | 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 | Before, 1 year and 2 years after the intervention |
| Relative expression of CD68 gene | Relative expression of CD68 gene in biopsied subcutaneous adipose tissue | Before, 1 year and 2 years after the intervention |
| Relative expression of MCP1 gene | Relative expression of MCP1 gene in biopsied subcutaneous adipose tissue | Before, 1 year and 2 years after the intervention |
| Relative expression of IL6 gene | Relative expression of IL6 gene in biopsied subcutaneous adipose tissue | Before, 1 year and 2 years after the intervention |
| Plasma levels of c-reactive protein | Levels of c-reactive protein in peripheral venous blood | Before, 1 year and 2 years after the intervention |
| Plasma Levels of ghrelin | Levels of ghrelin in peripheral blood | Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention |
| Plasma Levels of AgRP | Levels of AgRP in peripheral blood | Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention |
| Plasma Levels of GLP1 | Levels of GLP1 in peripheral blood | Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention |
| Serum Levels of insulin | Levels of insulin in peripheral blood | Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention |
| Serum Levels of glucose | Levels of glucose in peripheral blood | Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention |
| Serum Levels of glucagon | Levels of glucagon in peripheral blood | Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention |
| Serum Levels of GIP | Levels of GIP in peripheral blood | Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention |
| 25137427 | Derived | Reyes-Vidal C, Fernandez JC, Bruce JN, Crisman C, Conwell IM, Kostadinov J, Geer EB, Post KD, Freda PU. Prospective study of surgical treatment of acromegaly: effects on ghrelin, weight, adiposity, and markers of CV risk. J Clin Endocrinol Metab. 2014 Nov;99(11):4124-32. doi: 10.1210/jc.2014-2259. Epub 2014 Aug 19. |
| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |