A Prospective Study of Outcome After Therapy for Acromegaly
Acromegaly is a condition in which too much growth hormone is made by a tumor of the pituitary gland. Patients with inadequately treated acromegaly may have a higher chance of a number of other diseases such as heart disease, diabetes as well as a shortened life expectancy. The purpose of this study is to carefully characterize the blood levels of hormones and other substances in the blood in patients with acromegaly over time so that we can gain a better understanding of those factors responsible for the excess morbidity and mortality in acromegaly.
This study will follow acromegaly subjects during the therapy which has been decided by the patient and patient's physician. This study will not provide therapy for acromegaly. A patient qualifies as a possible study participant because the patient have been diagnosed with acromegaly.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Study of Outcome After Therapy for Acromegaly|
- Assessment of biochemical activity of acromegaly. [ Time Frame: At 5 years after therapy for acromegaly. ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
Serum and blood samples
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809808
|Contact: Pamela U Freda, M.D.||email@example.com|
|United States, New York|
|Neuroendocrine Unit; Columbia University Medical Center, 180 Fort Washington Avenue 9-970||Recruiting|
|New York, New York, United States, 10032|
|Contact: Carlos Reyes-Vidal, MD 212-305-4921|
|Contact: Jean Carlos Fernandez, MD 212-305-4921|
|Principal Investigator: Pamela U Freda, M.D.|
|Principal Investigator:||Pamela U Freda, M.D.||Columbia University|