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NCT00921609 · ClinicalTrials.gov registry record
Peri-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly
A clinical trial of Acromegaly, sponsored by Cedars-Sinai Medical Center.
- Active
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT00921609 is a study of Acromegaly that is active but no longer recruiting, run by Cedars-Sinai Medical Center. The registered enrollment target is 20 participants, below the 100-participant average among 13 other Acromegaly trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00921609, a study of Acromegaly, is active but no longer recruiting, sponsored by Cedars-Sinai Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Acromegaly is a rare disorder characterized by excessive production of growth hormone most often by a pituitary adenoma. A pituitary adenoma is a tumor, almost always benign or non-cancerous, that grows on the pituitary, a small gland located at the base of the brain. Treatment of acromegaly usually involves surgery, medication, or radiation, but can involve a combination of these three treatments. Subjects for this study will be recruited if they are: 1. Adults, male or female, between the ages of 18-90. 2. Have been diagnosed with acromegaly, based on elevated levels of growth hormone, IGF-I (a hormone made in response to growth hormone), and a pituitary adenoma visualized on an MRI. 3. Patients would have already agreed to have their acromegaly treated with surgery prior to study entry. Subjects will have measurements of growth hormone using an oral glucose tolerance test (OGTT), IGF-I, free IGF-I and levels of IGF binding proteins at four time points after their pituitary surgery: Day 1, Day 42 (6 weeks), Day 84 (12 weeks), and day 365 (1 year). Subjects will also have an MRI of the pituitary done at 12 weeks and 1 year. OGTT and IGF-I are routinely measured to assess whether or not a person is cured of their acromegaly. An MRI of the pituitary is routinely done at 12 weeks and 1 year after surgery to assess the results of surgery. Free IGF-I and IGF binding proteins are not routinely measured after surgery, but are being done to see if they relate more strongly to disease activity than IGF-I and growth hormone. OGTT and the IGF-I binding proteins are not routinely measured on the day after surgery, but are being done to examine the predictive ability of these tests at a very early time after surgery. Data obtained from these tests will be compared to the data gathered at the 1 year time point. IGF-I and growth hormone will be measured by a commercial clinical lab, Quest Diagnostics, for clinical decision-making at the time of service. IGF-I and growth horm
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Oral glucose tolerance test
Study Locations (1)
California
- Cedars-Sinai Medical Center, Pituitary Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2006-06 |
| Est. Completion | 2025-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00921609
The ClinicalTrials.gov registry entry for NCT00921609 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 13 other Acromegaly trials with a reported enrollment target (80% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acromegaly appearing as the primary indexed condition, and to 1 intervention - of which Oral glucose tolerance test is the first listed.
NCT00921609 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00921609 about?
NCT00921609 is a clinical study titled "Peri-operative Dynamics of the Growth Hormone Axis in Subjects With Acromegaly". Acromegaly is a rare disorder characterized by excessive production of growth hormone most often by a pituitary adenoma. A pituitary adenoma is a tumor, almost always benign or non-cancerous, that grows on the pituitary, a small gland located at the base of the brain. Treatment of acromegaly usually...
What is the current status of trial NCT00921609?
This trial is currently active not recruiting. The enrollment target is 20 participants. The study started on 2006-06. Estimated completion is 2025-04.
What conditions does trial NCT00921609 study?
This clinical trial studies the following conditions: Acromegaly.
What interventions are being tested in trial NCT00921609?
The interventions under investigation include: Oral glucose tolerance test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT00921609?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00921609 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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