A Prospective Study of Outcome After Therapy for Acromegaly
| Status: | Recruiting |
|---|---|
| Conditions: | Skin Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/21/2019 |
| Start Date: | September 2003 |
| End Date: | June 2020 |
| Contact: | Pamela U Freda, M.D. |
| Email: | puf1@cumc.columbia.edu |
| Phone: | 212-305-2254 |
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. The investigators 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.
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. The investigators 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.
Surgical removal of the pituitary tumor is the usual first form of treatment offered, but
this is curative in only approximately 70% of patients. If not adequately treated, the
disease can have significant morbidity largely due to the development of hypertension,
diabetes and malignancy as well as possible loss of vision or other neurologic complications
of a large pituitary mass. Inadequately treated acromegaly is also associated with a
mortality rate 2-3 fold over the general population. All the mechanisms responsible for the
increased morbidity and mortality in acromegaly as well as what biochemical criteria should
be used during treatment in order to normalize the increased morbidity and mortality are not
known. This study aims to follow patients with acromegaly prospectively from active disease
through treatment in order to identify these factors.
this is curative in only approximately 70% of patients. If not adequately treated, the
disease can have significant morbidity largely due to the development of hypertension,
diabetes and malignancy as well as possible loss of vision or other neurologic complications
of a large pituitary mass. Inadequately treated acromegaly is also associated with a
mortality rate 2-3 fold over the general population. All the mechanisms responsible for the
increased morbidity and mortality in acromegaly as well as what biochemical criteria should
be used during treatment in order to normalize the increased morbidity and mortality are not
known. This study aims to follow patients with acromegaly prospectively from active disease
through treatment in order to identify these factors.
Acromegaly Subjects
Inclusion Criteria:
- Adult males and females.
- Ages 18 and over.
- Presenting to the PI or one of the sub-investigators for evaluation of acromegaly.
- Must have a biochemical diagnosis of acromegaly consisting of an elevated serum
insulin-like growth factor 1 (IGF-1) level. Supportive although not required for entry
are an elevated growth hormone (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.
Healthy Subjects
Inclusion Criteria:
- Adult males and females.
- Ages 18 and over.
- Responding to ads for participation or by word of mount.
- No medical problems, no medications, stable weight for 3 months prior to study.
- 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.
- Failure to meet the inclusion criteria.
We found this trial at
1
site
New York, New York 10032
Principal Investigator: Pamela U Freda, M.D.
Phone: 212-305-4921
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