A Prospective Study of Outcome After Therapy for Acromegaly

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Columbia University
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University
ClinicalTrials.gov Identifier:
NCT01809808
First received: August 8, 2012
Last updated: May 13, 2015
Last verified: May 2015
  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. We 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:


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 2016
Estimated Primary Completion Date: June 2016 (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:

the first part of the study consists of an interview and examination of you performed by Dr. Freda or her research staff. Your examination will include measurement of your height, weight, waist and hip circumference with a tape measure. You will also be asked to complete a brief questionnaire to verify your health status. You will also have blood drawn for measurement of the following hormones: growth hormone, insulin-like growth factor-1(IGF-1), insulin, leptin, ghrelin, glucose, IGF binding proteins. Also at this visit you will have blood drawn at 60, 90, and 120 minutes after you drink an 8 ounce glass of sugar solution. Four separate blood samples will be taken by separate needlesticks. About 6 teaspoons of blood will be taken at this visit.

You will then come for visits at 1 week, 1month, 3months, 6months, and 12 months post operatively. At each visit you will have an interview and examination with Dr. Freda, Dr. Geer or their research staff, will complete a questionnaire about your symptoms of acromegaly. You will also have two teaspoons of blood drawn for measurement of the hormones listed above. At the 3 month and 12 month visits you will also have blood drawn for measurement of growth hormone and other hormones at 60, 90 and 120 minutes after you drink an 8 ounce glass of sugar solution (OGTT). About 6 teaspoons of blood will be drawn at these visits.

You will then be invited to come at yearly visits for the same procedures as listed above including the questionnaires, examination and blood testing including a OGTT. At your discretion or at the discretion of the research team the interval may be lengthened to every 2 to 3 years at some time in the future. It is expected that this study will continue for at least five years, but it may go beyond this time period.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 IGF-I level. Supportive although not required for entry are an elevated 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: Jean Carlos Fernandez, 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:
No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: May 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Acromegaly, Pituitary tumor

Additional relevant MeSH terms:
Pituitary Diseases
Acromegaly
Bone Diseases
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hyperpituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 28, 2015