A Prospective Study of Outcome After Therapy for Acromegaly - Full Text View

Purpose

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.

Condition	Intervention
Acromegaly	Procedure: Surgery for acromegaly Drug: Medications for acromegaly


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Prospective Study of Outcome After Therapy for Acromegaly

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Presence of of biochemical activity of acromegaly in subjects [ Time Frame: At 5 years after therapy for acromegaly ] [ Designated as safety issue: No ]
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 month 1 (fasting blood only), post-operative month 3 (fasting blood only), post-operative month 6, post-operative month 12, and annual assessments for at least 5 years.

Biospecimen Retention: Samples Without DNA

Serum and blood samples


Estimated Enrollment:	250
Study Start Date:	September 2003
Estimated Study Completion Date:	June 2020
Estimated Primary Completion Date:	June 2020 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 .	Procedure: Surgery for acromegaly (non-experimental) standard procedure Drug: Medications for acromegaly (non-experimental) standard procedure Other Name: Drugs used to lower growth hormone
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.

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate.

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809808

Contacts


Contact: Pamela U Freda, M.D.	212-305-2254	puf1@cumc.columbia.edu

Locations


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: Wayna Paulino, MD 212-305-4921
Principal Investigator: Pamela U Freda, M.D.

Sponsors and Collaborators

Columbia University

Icahn School of Medicine at Mount Sinai

Investigators


Principal Investigator:	Pamela U Freda, M.D.	Columbia University

More Information

Additional Information:

Columbia University Medical Center: Neuroendocrine Diseases Program This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Pamela U. Freda, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier:	NCT01809808 History of Changes
Other Study ID Numbers:	AAAA0890
Study First Received:	August 8, 2012
Last Updated:	August 4, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	Undecided

Keywords provided by 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

ClinicalTrials.gov processed this record on September 27, 2016