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

NCT00703079 | Completed

• 1 other identifier: NeuroendoUnit-10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Acromegaly

Keywords

Acromegaly; GH; IGF-I; Octreotide-LAR; Lanreotide; Transsphenoidal surgery

Outcome Measures

Primary Outcomes (1)

• Changes of fasting glucose levels.

  0, 6-12 and 60 months

Secondary Outcomes (1)

• changes in Hb1Ac levels changes in fasting insulin levels changes in HOMA-R index changes in HOMA-β index

  0, 6-12, 60 months

Study Arms (4)

Group A

\>15 patients treated only with SSA (octreotide-LAR or lanreotide depot)

Drug: Octreotide-LAR or lanreotide

Group B

\>15 patients treated with surgery after a period of SSA treatment of 6-24 months

Drug: Octreotide-LAR or lanreotide; Procedure: Transsphenoidal adenomectomy

Group C

\>15 patients cured after surgery only

Procedure: Transsphenoidal adenomectomy

Group D

\>15 patients treated with surgery first and then with SSA after 6-12 months

Drug: Octreotide-LAR or lanreotide; Procedure: Transsphenoidal adenomectomy

Interventions

Octreotide-LAR or lanreotide DRUG

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

Also known as: Sandostatin-LAR (Novartis), Ipstyl (Ipsen)

Group A; Group B; Group D

Transsphenoidal adenomectomy PROCEDURE

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

Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will review all files from consecutive patients with active acromegaly coming to the Units of Endocrinology or Neurosurgery of the "Federico II" University of Naples from Jan 1st 1997 to June 1st 2008, primarily treated with either surgery or depot SSA, i.e. lanreotide (LAN) or slow-release octreotide (LAR), and with an available follow-up of at least 60 months. Due to the study design, this is a non ran-domized study. However, our routine procedure generally considers first-line treatment with SSA for 6-12 months, unless the tumors are clearly non invasive on Magnetic Resonance Imaging (MRI) and/or the patients who do not present any surgical or anesthesiological risk.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples

Naples, 80131, Italy

Location

Related Publications (8)

• Colao A, Ferone D, Marzullo P, Lombardi G. Systemic complications of acromegaly: epidemiology, pathogenesis, and management. Endocr Rev. 2004 Feb;25(1):102-52. doi: 10.1210/er.2002-0022.

  PMID: 14769829 RESULT

• 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. doi: 10.2165/00024677-200504010-00005.

  PMID: 15649100 RESULT

• 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 (Oxf). 2000 May;52(5):549-55. doi: 10.1046/j.1365-2265.2000.00986.x.

  PMID: 10792333 RESULT

• 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. doi: 10.1056/NEJM198512193132504.

  PMID: 2866445 RESULT

• 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: 10.1210/jc.2008-0299. Epub 2008 Apr 29.

  PMID: 18445662 RESULT

• 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. doi: 10.1530/EJE-07-0383.

  PMID: 17984237 RESULT

• 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) Study Group. J Endocrinol Invest. 2006 Dec;29(11):1017-20. doi: 10.1007/BF03349217. No abstract available.

  PMID: 17259801 RESULT

• Colao A, Auriemma RS, Galdiero M, Cappabianca P, Cavallo LM, Esposito F, Grasso LF, Lombardi G, Pivonello R. Impact of somatostatin analogs versus surgery on glucose metabolism in acromegaly: results of a 5-year observational, open, prospective study. J Clin Endocrinol Metab. 2009 Feb;94(2):528-37. doi: 10.1210/jc.2008-1546. Epub 2008 Nov 11.

  PMID: 19001517 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sera from most patients on a yearly bases are stored in our freezed at minus 80° for eventual further studies. No experimental parameters are included in the current study.

MeSH Terms

Conditions

Acromegaly

Interventions

lanreotide; lactitol

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Annamaria Colao, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 23, 2008
• Study Start: January 1, 1997
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 23, 2008

Record last verified: 2008-06

Locations

IT (1)