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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03309319
Enrollment
24
Registered
2017-10-13
Start date
2016-10-16
Completion date
2018-12-31
Last updated
2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Tumor

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.

Interventions

DRUGRosiglitazone

rosiglitazone is added to the primary treatment

Sponsors

Zhaoyun Zhang
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Growth hormone(GH)6 monthsthe decrease of growth hormone(GH)
insulin like factor 1(IGF-1)6 monthsthe decrease of insulin like factor 1(IGF-1)
tumor volume6 monthsthe change of tumor volume

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026