Overview

Impact of Somatostatin Analogs vs. Surgery on Glucose Metabolism in Acromegaly

Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate the 60 month impact of surgery and somatostatin analogues (SSA) on glucose metabolism in acromegaly we will analyzed data from 100 patients with acromegaly according with different treatments (group A=with SSA only; group B= SSA followed by surgery; group C= surgery only; group D= surgery followed by SSA). At diagnosis and after 6-12 and 60 months were analyzed as primary outcome measure changes in fasting glucose and as secondary outcome measures changes of glycated hemoglobin (HbA1c) and insulin levels, HOMA-R and HOMA-β, representing insulin resistance and β-cell function, respectively. We will enrol 100 patients and expect half of them to have IGT or diabetes mellitus. We do not expect changes according with different treatment after 60 months while SSA-treated patients might experience deterioration of glucose tolerance after 6-12 months. We intend to look for predictors of deterioration of glucose tolerance.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Federico II University
Treatments:
Angiopeptin
Lanreotide
Octreotide
Somatostatin
Criteria
Inclusion Criteria:

- Patients treated with either first-line surgery via trans-sphenoidal route by
microscopic and/or endoscopic approach or with first-line depot SSA treatment, or both
and

- Patients with available follow-up after 60 months of treatment

Exclusion Criteria:

- Patients requiring dopamine-agonists or pegvisomant

- Patients receiving the s.c. octreotide for longer than 15 days

- Patients receiving radiotherapy,

- Patients with a follow-up shorter than 60 months