A Prospective Study of Outcome After Therapy for Acromegaly
Key facts
- Who runs it
- Columbia University
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 280 people enrolled
- Started
- Sept 2003
- Ended
- Aug 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Surgery for acromegaly
- Medications for acromegaly
- Total body magnetic resonance imaging
- Adipose Tissue Biopsy
- Record updated
- 26 August 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
- 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
Who cannot take part
- Failure to meet the inclusion 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
- 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
Other criteria
- Acromegaly Subjects
Where in United States
- Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970New York, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 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.
Treatment: Surgery for acromegaly, Medications for acromegaly, Total body magnetic resonance imaging, and Adipose Tissue Biopsy
- 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.
Treatment: Total body magnetic resonance imaging and Adipose Tissue Biopsy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 26 August 2025