A Prospective Study of Outcome After Therapy for Acromegaly (NCT01809808) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Study of Outcome After Therapy for Acromegaly
United States280 participantsStarted 2003-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biochemical activity of Acromegaly
Timeframe: At 5 years after therapy for acromegaly