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
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
Observational Model: Cohort, Time Perspective: Prospective
Assessment of biochemical activity of acromegaly.
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.
At 5 years after therapy for acromegaly.
Pamela U Freda, M.D.
United States: Institutional Review Board
|Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970||New York, New York 10032|