A Prospective Study of Outcome After Therapy for Acromegaly
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Purpose
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.
| Condition |
|---|
|
Acromegaly |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 250 |
| 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) |
| Groups/Cohorts |
|---|
| Acromegaly Subjects |
| Healthy Subjects |
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects newly diagnosed with acromegaly or who have previously undergone surgery for acromegaly are invited to participate. Acromegaly subjects will be recruited primarily from the patients who present to Dr. Jeffrey Bruce at Columbia Presbyterian Medical Center, Dr. Kalmon Post at Mount Sinai Medical Center for Neurosurgery or to the Principal Investigator Dr. Pamela Freda at the Neuroendocrine Unit at Columbia Presbyterian Medical Center for evaluation of acromegaly. Subjects who have undergone surgery with other surgeons or followed by other Endocrinologists may be considered for participation.
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
Contacts and Locations| Contact: Pamela U Freda, M.D. | 212-305-2254 | puf1@columbia.edu |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pamela U. Freda, Associate Professor of Medicine, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01809808 History of Changes |
| Other Study ID Numbers: | AAAA0890 |
| Study First Received: | August 8, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
Acromegaly, Pituitary tumor |
Additional relevant MeSH terms:
|
Acromegaly Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases Hyperpituitarism Pituitary Diseases |
Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013