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NCT00703079: GLUSSA
Impact of Somatostatin Analogs vs. Surgery on Glucose Metabolism in Acromegaly: Results of a 5 Years Observational, Open, Prospective Study
trial testing Octreotide-LAR or lanreotide in Acromegaly in 100 participants. Completed in 1 June 2008.
1 June 2008
Quick facts
| Lead sponsor | Federico II University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 January 1997 |
| Primary completion | 1 June 2008 |
| Estimated completion | 1 June 2008 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Octreotide-LAR or lanreotide — full drug profile →
- Transsphenoidal adenomectomy
Conditions studied
- Acromegaly — all drugs for Acromegaly →
Sponsor
Federico II University
Who can join
Adults 18 to 80, any sex, with Acromegaly. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Changes of fasting glucose levels.
Time frame: 0, 6-12 and 60 months
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00703079
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acromegaly
Currently open trials in the same condition.
- NCT07037420 — ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly · Phase 2 · recruiting
- NCT05401084 — Diet in the Management of Acromegaly · NA · recruiting
- NCT05131100 — Korean Regulatory Post Marketing Surveillance for Somavert · recruiting
- NCT05964712 — Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study · recruiting
- NCT03158090 — The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research · recruiting
Other Federico II University trials
Trials by the same sponsor.
- NCT07437690 — Fall Prevention in Older Adults in an Italian Cohort · not yet recruiting
- NCT07282132 — Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter · not yet recruiting
- NCT07280286 — Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel · NA · not yet recruiting
- NCT07374861 — Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy · recruiting
- NCT07314684 — GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00703079 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federico II University
- Last refreshed: 20 June 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00703079.
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