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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03309319
Other study ID # KY2016-360
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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