Clinical trial NCT01809808: A Prospective Study of Outcome After Therapy for Acromegaly
Official title: A Prospective Study of Outcome After Therapy for Acromegaly
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acromegaly
Keywords: Acromegaly
Pituitary tumor
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-03-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemical activity of Acromegaly
timeFrame: At 5 years after therapy for acromegaly
Secondary outcomes:
measure: Visceral Adipose Tissue Mass
timeFrame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
measure: Intra-hepatic Lipid
timeFrame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
measure: Resting metabolic rate
timeFrame: Before, 1 year and 2 years after the intervention
measure: Intra-myocellular lipid
timeFrame: Before therapy, 6 months, 1 year and 2 years after the intervention, surgery or medical therapy.
measure: Relative expression of CD11c gene
timeFrame: Before, 1 year and 2 years after the intervention
measure: Relative expression of CD68 gene
timeFrame: Before, 1 year and 2 years after the intervention
measure: Relative expression of MCP1 gene
timeFrame: Before, 1 year and 2 years after the intervention
measure: Relative expression of IL6 gene
timeFrame: Before, 1 year and 2 years after the intervention
measure: Plasma levels of c-reactive protein
timeFrame: Before, 1 year and 2 years after the intervention
measure: Plasma Levels of ghrelin
timeFrame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
measure: Plasma Levels of AgRP
timeFrame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
measure: Plasma Levels of GLP1
timeFrame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
measure: Serum Levels of insulin
timeFrame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
measure: Serum Levels of glucose
timeFrame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
measure: Serum Levels of glucagon
timeFrame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
measure: Serum Levels of GIP
timeFrame: Before, 1 month, 3 months, 6 months, 1 year and 2 years after intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970
state: New York
Study officials:
affiliation: Columbia University
name: Pamela U Freda, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.