View Clinical Trial (Medical Research Study)
A Study Examining the Peri- and Post-operative Dynamics of the GH-IGF-1 Axis in Subjects With Acromegaly During the First Year After Surgical Resection
| City: |
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Los Angeles |
| State: |
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California |
| Zip Code: |
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90048 |
| Conditions: |
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Acromegaly |
| Purpose: |
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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 hormone will also be
measured using other methods to attempt to investigate the variability of these hormones
when different assays are used.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Male or Female age 18-90
- Diagnosed with acromegaly from a pituitary adenoma visualized by MRI, and with
elevated IGF-1 levels compared to age and gender matched control values and nadir GH
response to OGTT>1mg/L
- Having already agreed to undergo surgical resection of their pituitary adenoma prior
to study entry
- Must provide informed consent
Exclusion Criteria:
- Inability to complete the protocol due to intercurrent medical or psychiatric illness
- Pregnant or breastfeeding
- Use of insulin
- Use of estrogen, progesterone, testosterone or thyroid hormone will be allowed as
long as the dose is stable during the study
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| NCT ID: |
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NCT00921609 |
| Primary Contact: |
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Principal Investigator
John Carmichael, MD
Cedars-Sinai Medical Center
Lori Korsakoff, RN
Phone: 310-423-2411
Email: korsakoffl@cshs.org
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| Backup Contact: |
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Email: Billy.Gellepis@cshs.org
Billy Gellepis
Phone: 310-423-3395
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| Location Contact: |
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Los Angeles, California 90048
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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