Pituitary TumorNCT03309319
A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
A study testing Rosiglitazone in people with Pituitary Tumor, run by Zhaoyun Zhang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pituitary Tumor
- What is being tested?
- Rosiglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Min He, Doctor, +862152887027, mhe2004@263.net
Zhaoyun Zhang, Professor
About this study
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.
- Conditions
- Pituitary Tumor
- Being tested
- Rosiglitazone
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
rosiglitazone is added to the primary treatment
| Study group | Role | What they receive |
|---|---|---|
| Ros | Experimental | Rosiglitazone：2 times a day, 4mg each time（4mgBid） Receives: Drug: Rosiglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth hormone(GH)
the decrease of growth hormone(GH)
Measured: 6 months
insulin like factor 1(IGF-1)
the decrease of insulin like factor 1(IGF-1)
Measured: 6 months
tumor volume
the change of tumor volume
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start16 Oct 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhaoyun Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhaoyun Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309319
- Sponsor's protocol ID
- KY2016-360
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
- ClinicalTrials.gov ID
- NCT03309319
- Acronym / sponsor ID
- KY2016-360
- Conditions
- Pituitary Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zhaoyun ZhangUniversity, hospital or other
- Study start
- 16 Oct 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ros | Experimental | Drug: RosiglitazoneRosiglitazone：2 times a day, 4mg each time（4mgBid） |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosiglitazonerosiglitazone is added to the primary treatment | Drug | Ros |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosiglitazone in people with Pituitary Tumor, run by Zhaoyun Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth hormone(GH) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.