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

Pituitary Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03309319
• Other study ID #: KY2016-360
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 9, 2017
• Start date: October 16, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2017
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Growth Hormone-Secreting Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Intervention

Drug:
• Rosiglitazone
rosiglitazone is added to the primary treatment

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhaoyun Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth hormone(GH)	the decrease of growth hormone(GH)	6 months
Primary	insulin like factor 1(IGF-1)	the decrease of insulin like factor 1(IGF-1)	6 months
Primary	tumor volume	the change of tumor volume	6 months