A Prospective Study of Outcome After Therapy for Acromegaly
18 Years
N/A
Both
Acromegaly
Trial Information
A Prospective Study of Outcome After Therapy for Acromegaly
Patients will be seen at diagnosis and over time after surgery if they are newly diagnosed
or if they have already undergone surgery they will be seen over time after surgery. Visits
will occur preoperatively and at 1, 3, 6, 12 months after surgery and then yearly for at
least 5 years after that. Subjects who enter the study 1 year after surgery or later will be
seen yearly for at least 5 years .
At each visit subjects will have an interview and examination with Dr. Freda or her research
staff, will complete a questionnaire about symptoms of acromegaly. You will also have two
teaspoons of blood drawn for measurement of the hormones listed above. At the 3 month and
12 month visits subjects will also have blood drawn for measurement of growth hormone and
other hormones at 60, 90 and 120 minutes after they drink an 8 ounce glass of sugar
solution (OGTT).
About 6 teaspoons of blood will be drawn at these visits.
Subjects will then invited to come at yearly visits for the same procedures as listed above
including the questionnaires, examination and blood testing including a OGTT. At your
discretion or at the discretion of the research team the interval may be lengthened to every
2 to 3 years at some time in the future. It is expected that this study will continue for
at least five years, but it may go beyond this time period.
If subjects receive another form of therapy for acromegaly visits will take place at the
time intervals above during the course of your therapy.
If subjects have undergone surgery at some time in the past they may join the study at any
point in itscourse and undergo the procedures described above as appropriate
Inclusion Criteria:
- Adult males and females
- Ages 18 and over
- Presenting to the PI or one of the sub-investigators for evaluation of acromegaly or
for study participation to the PI or a sub-investigator.
- Must have a biochemical diagnosis of acromegaly consisting of an elevated serum IGF-I
level. Supportive although not required for entry are an elevated 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Assessment of biochemical activity of acromegaly.
Outcome Description:
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 month 1(fasting blood only), post-operative month 3(fasting blood only), post-operative month 6, post-operative month 12, and annual assessments for at least 5 years.
Outcome Time Frame:
At 5 years after therapy for acromegaly.
Safety Issue:
No
Principal Investigator
Pamela U Freda, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Columbia University
Authority:
United States: Institutional Review Board
Study ID:
AAAA0890
NCT ID:
NCT01809808
Start Date:
September 2003
Completion Date:
June 2016
Related Keywords:
- Acromegaly
- Acromegaly, Pituitary tumor
- Acromegaly
Name | Location |
|---|---|
| Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970 | New York, New York 10032 |
