IGF-1 Level on Sandostatin LAR
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Open Label Dose Escalation of Sandostatin LAR Therapy | 336 | 209 |
| Responders | 186 | 42.4 |
| Non Responders | 487 | 200.4 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF-1) normalization into current IGF-I normal ranges with Sandostatin LAR® therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.
Experimental
Sandostatin LAR
Nine months of open label dose escalation Sandostatin LAR therapy.
Outcomes the sponsor listed as primary.
IGF-1 Level on Sandostatin LAR
Time frame · Up to 9 months
Mean IGF-1 level on treatment with Sandostatin LAR in whole population and responders (normal IGF1) and non responders(elevated IGF-1)
Cardiovascular Risk Markers on Sandostatin LAR: C-reactive Protein (CRP) Levels
Time frame · Up to 9 months
Levels of C-reactive protein (CRP) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.
Cardiovascular Risk Markers on Sandostatin LAR: Homocysteine Levels
Time frame · Up to 9 months
Levels of homocysteine in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.
Cardiovascular Risk Markers on Sandostatin LAR: Lipid Levels
Time frame · Up to 9 months
Levels of lipid panel (cholesterol, triglycerides, and Lipoprotein A) in whole study group, responders (normal IGF-1) and non responders (elevated IGF-1) groups. Higher values are a worse outcome.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Open Label Dose Escalation of Sandostatin LAR Therapy | 336 | 209 |
| Responders | 186 | 42.4 |
| Non Responders | 487 | 200.4 |
| Group | Value (mg/L) | Spread |
|---|---|---|
| Open Label Dose Escalation of Sandostatin LAR Therapy | 2.05 | 3.5 |
| Responders | 2.89 | 4.79 |
| Non Responders | 1.21 | 1.2 |
| Group | Value (µmol/L) | Spread |
|---|---|---|
| Open Label Dose Escalation of Sandostatin LAR Therapy | 9.98 | 5.8 |
| Responders | 10.57 | 5.56 |
| Non Responders | 9.40 | 6.4 |
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Open Label Dose Escalation of Sandostatin LAR Therapy | 173.75 | 42.9 |
| Responders | 182.44 | 49.78 |
| Non Responders | 162.57 | 32.1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Open Label Dose Escalation Study of Sandostatin LAR TherapyAcromegaly is a rare disorder due in almost all cases to a GH secreting tumor of the pituitary gland. The initial treatment is typically surgical removal of the tumor, but after this many patients have residual disease requiring additional therapy. For most patients this therapy is medical with a somatostatin analog. In addition to biochemical control, important and often overlooked goals of acromegaly care are to treat its associated co-morbidities in particular insulin resistance and diabetes mellitus, hypertension and cardiovascular (CV) disease. Changes in body composition in acromegaly may be integral to the development of insulin resistance and increased CV risk. Therefore, this study sought to examine the effect of lowering of serum IGF-I levels into the current more stringent normal range during treatment with octreotide LAR on metabolic parameters, body composition and cardiovascular risk profile in patients with acromegaly. | – | 0 / 18 | 0 / 18 |
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