A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
- Registration Number
- NCT03309319
- Lead Sponsor
- Zhaoyun Zhang
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ros Rosiglitazone Rosiglitazone：2 times a day, 4mg each time（4mgBid）
- Primary Outcome Measures
Name Time Method Growth hormone(GH) 6 months the decrease of growth hormone(GH)
tumor volume 6 months the change of tumor volume
insulin like factor 1(IGF-1) 6 months the decrease of insulin like factor 1(IGF-1)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Huashan Hospital
🇨🇳Shanghai, Shanghai, China