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

Zhaoyun Zhang

Status

Unknown

Conditions

Pituitary Tumor

Treatments

Drug: Rosiglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT03309319

KY2016-360

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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