A Prospective Study of Outcome After Therapy for Acromegaly
The purpose of this study is to evaluate hormone values and other markers of disease activity in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after surgical or other treatment. This study is designed to determine blood levels of growth hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of the disease at diagnosis and how these parameters change over time after surgical or other therapy. We will also obtain hormonal data in a group of 50 healthy subjects who will each be studied just once with an oral glucose tolerance test (OGTT). These data will provide a comparison group to the acromegaly subjects.
Procedure: Surgery for acromegaly
Drug: Medications for acromegaly
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Study of Outcome After Therapy for Acromegaly|
- Presence of of biochemical activity of acromegaly in subjects [ 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)|
People who have a biochemical diagnosis of acromegaly, and will or have already undergone surgery for acromegaly and will be taking medications for acromegaly .
Procedure: Surgery for acromegaly
(non-experimental) standard procedureDrug: Medications for acromegaly
(non-experimental) standard procedure
Other Name: Drugs used to lower growth hormone
People who are not diagnosed with acromegaly, responding to flyer or by word of mouth for participation, without medical problems, not taking medications, and with a stable weight for 3 months prior to study.
the first part of the study consists of an interview and examination of you performed by Dr. Freda or her research staff. Your examination will include measurement of your height, weight, waist and hip circumference with a tape measure. You will also be asked to complete a brief questionnaire to verify your health status. You will also have blood drawn for measurement of the following hormones: growth hormone, insulin-like growth factor-1(IGF-1), insulin, leptin, ghrelin, glucose, IGF binding proteins. Also at this visit you will have blood drawn at 60, 90, and 120 minutes after you drink an 8 ounce glass of sugar solution. Four separate blood samples will be taken by separate needlesticks. About 6 teaspoons of blood will be taken at this visit.
You will then come for visits at 1 week, 1month, 3months, 6months, and 12 months post operatively. At each visit you will have an interview and examination with Dr. Freda, Dr. Geer or their research staff, will complete a questionnaire about your 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 you will also have blood drawn for measurement of growth hormone and other hormones at 60, 90 and 120 minutes after you drink an 8 ounce glass of sugar solution (OGTT). About 6 teaspoons of blood will be drawn at these visits.
You will then be 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01809808
|Contact: Pamela U Freda, M.D.||firstname.lastname@example.org|
|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|