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

NCT00703079 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2008-06-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Octreotide-LAR or lanreotide

Treated with octreotide-LAR will be given at dosages of 10-40 mg/q28d and treatment with lanreotide-SR at dosages of 60-120 mg/q28d. The dosages are up-titrated to control GH and IGF-I levels

PROCEDURE

Transsphenoidal adenomectomy

Removal of pituitary adenomas via one-nostril transsphenoidal approach and endoscopy-assisted.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Annamaria Colao, MD · Federico II University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-01-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00703079 on ClinicalTrials.gov