Effects of Sandostatin LAR® in Acromegaly
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change in IGF-1 levels [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
- Change in lab results of cardiovascular risk profile in LAR® treated patients. [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]Includes C-reactive protein (CRP), IL-6, as well as homocysteine, lipoprotein, and lipid panel results.
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: Sandostatin LAR
This is a 9 month, open label dose escalation study of Sandostatin LAR therapy.
Drug: Sandostatin LAR
This will be a open label dose escalation study of Sandostatin LAR 10 Mg, 20Mg, 30 Mg up to 40 mg if necessary.
-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424241
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Pamela U Freda, MD||Columbia University|