A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas

NCT03309319 — Not applicable, Unknown, 24 participants, Zhaoyun Zhang

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Registry	NCT03309319
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	24 (Estimated)
Sponsor	Zhaoyun Zhang (Other)
Conditions	Pituitary Tumor
Interventions	Rosiglitazone (Drug)
Dates	start 2016-10-16, primary completion 2018-12-31 (estimated), completion 2018-12-31 (estimated), first posted 2017-10-13, last updated 2017-10-13
Locations	1 site in China

-Summary

Growth hormone secreting pituitary adenomas(GHomas) produce excessive GH, stimulating excessive insulin like growth factor 1(IGF-1) synthesis in the liver, thus causing multiple systemic complications. The life expectancy of patients with untreated GHomas is shortened by ten years. The treatment goal of GHomas is to shrink the tumor volume and normalize GH and IGF-1. Under current treatment, only 50-70% of patients get remission. Rosiglitazone is a widely used oral antidiabetic medicine. The investigator's preliminary data showed that rosiglitazone decreased the synthesis of GH and IGF-1 in rat pituitary tumor cells GH3 and hepatocytes respectively. The investigator plan to investigate the efficacy of rosiglitazone in the treatment of patients with GHomas who have not been alleviated by other therapies.

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+Arms and interventions

Arm	Type	Interventions	Description
Ros	Experimental	Drug: Rosiglitazone	Rosiglitazone：2 times a day, 4mg each time（4mgBid）

Rosiglitazone (Drug): rosiglitazone is added to the primary treatment

+Outcome measures

Primary outcomes

Growth hormone(GH) [6 months]: the decrease of growth hormone(GH)
insulin like factor 1(IGF-1) [6 months]: the decrease of insulin like factor 1(IGF-1)
tumor volume [6 months]: the change of tumor volume

+Eligibility

Sex: All, ages: 20 Years to 60 Years

Inclusion Criteria:

* Patients with GHomas confirmed by surgery
* Patients who did not get biochemical remission: GH nadir after oral glucose tolerance test（OGTT）>1.0ug/L or IGF-1 exceeds age matched normal range

Exclusion Criteria:

* Patients who were allergic to rosiglitazone
* Patients with liver or kidney dysfunction, respiratory failure
* Patients with heart failure
* Patients with edema
* Patients with severe hyperlipidemia
* Patients with osteoporosis or a history of non traumatic fractures
* Patients with pregnancy and lactation
* Patients who had received radiation therapy within 3 years
* Patients who had participated in other clinical trials within 3 months
* Patients with other neoplastic diseases
* Patients with mental and neurological disorders
* Patients with other conditions which were believed not appropriate to take part in the clinical trial

+Locations (1)

Facility	City	Country	Status
Huashan Hospital	Shanghai, Shanghai Municipality	China	Recruiting