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NCT01809808 · ClinicalTrials.gov registry record
A Prospective Study of Outcome After Therapy for Acromegaly
A clinical trial, sponsored by Columbia University.
- Completed
- Registry status
- 280
- Enrollment target
NCT01809808: Completed study, sponsored by Columbia University.
NCT01809808 is a clinical trial that has completed, run by Columbia University. The registered enrollment target is 280 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01809808 has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- 280 participants
- Enrollment target
Study 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.
Primary Outcome
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 or after the initiation of medical therapy at month 1 (fasting blood only), month 3 (fasting blood only), month 6, month 12, and annual assessments for at least 5 years.
Interventions
- PROCEDURE Adipose Tissue Biopsy
- PROCEDURE Surgery for acromegaly
- DRUG Medications for acromegaly
- DIAGNOSTIC_TEST Total body magnetic resonance imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2003-09 |
| Est. Completion | 2025-08 |
What the finished NCT01809808 record still lists
NCT01809808 is an observational study that tracks outcomes without assigning an intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which Adipose Tissue Biopsy is the first listed.
NCT01809808 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01809808 about?
NCT01809808 is a clinical study titled "A Prospective Study of Outcome After Therapy for Acromegaly". 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 horm...
What is the current status of trial NCT01809808?
This trial is currently completed. The enrollment target is 280 participants. The study started on 2003-09. Estimated completion is 2025-08.
What interventions are being tested in trial NCT01809808?
The interventions under investigation include: Adipose Tissue Biopsy (PROCEDURE), Surgery for acromegaly (PROCEDURE), Medications for acromegaly (DRUG), Total body magnetic resonance imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT01809808?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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