Acromegaly Clinical Trial
Official title:
Metabolic, Cardiovascular and Body Composition Effects of Sandostatin LAR® Therapy of Acromegaly, Effect of Reduction of Serum Insulin-like Growth Factor 1 (IGF-1) Levels Into a New Normative Range
This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF1) normalization into current IGF1 normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.
-Study Purpose: The purpose of this study is to assess the effect of IGFI normalization with
Sandostatin LAR® therapy on metabolic abnormalities, cardiovascular risk profile and body
composition in patients with active acromegaly.
-Study Design: This is an open label,single center, prospective study. Patients with active
acromegaly who have not received prior somatostatin analog therapy will receive sandostatin
LAR® for 9 months. Assessments will include laboratory testing, intravenous glucose tolerance
tests, signs and symptoms questions, cardiac echocardiography (ECHO) and Dual-emission X-ray
absorptiometry (DEXA) body composition before and at the end of the 9 months of therapy.
The primary endpoints of the analysis are change in insulin sensitivity, change in
cardiovascular risk marker, change in biochemical markers of the Growth Hormone (GH)/IGF1
axis, change in ECHO determined cardiac parameters and change in body composition such as
increase in total body fat or decrease in lean body mass.
- Study Subjects A total of 20 subjects total at this site will be enrolled. Subjects will
be recruited based on the inclusion and exclusion criteria from the protocol out of the
patients who are seen at our Neuroendocrine unit for evaluation of acromegaly.
- Recruitment Method Subjects will be recruited from those presenting to the
Neuroendocrine Unit for evaluation of acromegaly. Subjects will be recruited by the PI
after they have been approached by their physician and expressed an interest in study
participation.
- Study Procedures Subjects will come to the Neuroendocrine Unit for visits monthly during
the study period and administration of study drug. Patients will have their doses
titrated based on IGF1 level as per the study protocol. Patients will undergo laboratory
testing, physical examinations, ECHO, DEXA and other noninvasive questionnaires and
monitoring as specified by the protocol over the course of the study.
- Issues Small risks include possible pain and bruising at the site of the needle
insertion for blood drawing. Sandostatin LAR® is associated with gastrointestinal side
effects such as bloating and diarrhea which usually subside. About 15% of patients
treated with this medication develop gallstones. These usually remain asymptomatic.
Pituitary tumors may also change in size during these medical therapies.
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