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Status unknownNCT03309319Updated Oct 13, 2017

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

An interventional study of Rosiglitazone in Pituitary Tumor, sponsored by Zhaoyun Zhang. Status unknown at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-10-13.

Sponsored by Zhaoyun Zhang · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Oct 2016, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pituitary Tumor

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03

In context

Pituitary Neoplasms

200 studies on the registry are indexed under Pituitary Neoplasms; 51 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 121 interventional studies indexed under Pituitary Neoplasms.

Browse Pituitary Neoplasms studies →

Lead sponsor

Zhaoyun Zhang is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Ros

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

    Drug: Rosiglitazone

Interventions

06

What researchers measure

Primary outcomes

  1. Growth hormone(GH)

    the decrease of growth hormone(GH)

    Time frame: 6 months

  2. insulin like factor 1(IGF-1)

    the decrease of insulin like factor 1(IGF-1)

    Time frame: 6 months

  3. tumor volume

    the change of tumor volume

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Huashan Hospital
    Shanghai, Shanghai 200040, China
    Recruiting
    • Min He, Doctor · Contactmhe2004@263.net · +862152887027
    • Zhaoyun Zhang, Professor · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2016 (actual). Primary completion is estimated for Dec 2018, 26 months after the start.

Of 46 interventional studies with no phase under Pituitary Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 26 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2017
First posted
Oct 13, 2017
StartActual
Oct 16, 2016
Primary completionEst.
Dec 31, 2018
CompletionEst.
Dec 31, 2018
Last update
Oct 13, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03309319
Lead sponsor
Zhaoyun Zhang
Responsible party
Zhaoyun Zhang (professor, Huashan Hospital) — Sponsor-investigator
First posted
Oct 13, 2017
Start date
Oct 16, 2016
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Oct 13, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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