Acromegaly Clinical Trial
— GLUSSAOfficial title:
Impact of Somatostatin Analogs vs. Surgery on Glucose Metabolism in Acromegaly: Results of a 5 Years Observational, Open, Prospective Study
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
Colao A, Ferone D, Marzullo P, Lombardi G. Systemic complications of acromegaly: epidemiology, pathogenesis, and management. Endocr Rev. 2004 Feb;25(1):102-52. Review. — View Citation
Colao A, Martino E, Cappabianca P, Cozzi R, Scanarini M, Ghigo E; A.L.I.C.E. Study Group. First-line therapy of acromegaly: a statement of the A.L.I.C.E. (Acromegaly primary medical treatment Learning and Improvement with Continuous Medical Education) Stu — View Citation
Colao A, Pivonello R, Auriemma RS, Galdiero M, Savastano S, Lombardi G. Beneficial effect of dose escalation of octreotide-LAR as first-line therapy in patients with acromegaly. Eur J Endocrinol. 2007 Nov;157(5):579-87. — View Citation
Colao A, Pivonello R, Galderisi M, Cappabianca P, Auriemma RS, Galdiero M, Cavallo LM, Esposito F, Lombardi G. Impact of treating acromegaly first with surgery or somatostatin analogs on cardiomyopathy. J Clin Endocrinol Metab. 2008 Jul;93(7):2639-46. doi — View Citation
Kasayama S, Otsuki M, Takagi M, Saito H, Sumitani S, Kouhara H, Koga M, Saitoh Y, Ohnishi T, Arita N. Impaired beta-cell function in the presence of reduced insulin sensitivity determines glucose tolerance status in acromegalic patients. Clin Endocrinol ( — View Citation
Lamberts SW, Uitterlinden P, Verschoor L, van Dongen KJ, del Pozo E. Long-term treatment of acromegaly with the somatostatin analogue SMS 201-995. N Engl J Med. 1985 Dec 19;313(25):1576-80. — View Citation
Pereira AM, Biermasz NR, Roelfsema F, Romijn JA. Pharmacologic therapies for acromegaly: a review of their effects on glucose metabolism and insulin resistance. Treat Endocrinol. 2005;4(1):43-53. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of fasting glucose levels. | 0, 6-12 and 60 months | Yes | |
Secondary | changes in Hb1Ac levels changes in fasting insulin levels changes in HOMA-R index changes in HOMA-ß index | 0, 6-12, 60 months | Yes |
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