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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

Interventions

  • Drug: Rosiglitazone
    • rosiglitazone is added to the primary treatment

Arms, Groups and Cohorts

  • Experimental: Ros
    • Rosiglitazone:2 times a day, 4mg each time(4mgBid)

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhaoyun Zhang
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Zhaoyun Zhang, professor – Huashan Hospital

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