Back to resultsA Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
Primary Purpose
Pituitary Tumor
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Tumor
Eligibility Criteria
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
Sites / Locations
- Huashan HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ros
Arm Description
Rosiglitazone：2 times a day, 4mg each time（4mgBid）
Outcomes
Primary Outcome Measures
Growth hormone(GH)
the decrease of growth hormone(GH)
insulin like factor 1(IGF-1)
the decrease of insulin like factor 1(IGF-1)
tumor volume
the change of tumor volume
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03309319
Brief Title
A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
Official Title
A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhaoyun Zhang
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ros
Arm Type
Experimental
Arm Description
Rosiglitazone：2 times a day, 4mg each time（4mgBid）
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Intervention Description
rosiglitazone is added to the primary treatment
Primary Outcome Measure Information:
Title
Growth hormone(GH)
Description
the decrease of growth hormone(GH)
Time Frame
6 months
Title
insulin like factor 1(IGF-1)
Description
the decrease of insulin like factor 1(IGF-1)
Time Frame
6 months
Title
tumor volume
Description
the change of tumor volume
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min He, Doctor
Phone
+862152887027
Email
mhe2004@263.net
First Name & Middle Initial & Last Name & Degree
Zhaoyun Zhang, Professor
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
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