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

NCT ID: NCT03309319

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-16

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pituitary Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ros

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

Group Type EXPERIMENTAL

Rosiglitazone

Intervention Type DRUG

rosiglitazone is added to the primary treatment

Interventions

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Rosiglitazone

rosiglitazone is added to the primary treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhaoyun Zhang

OTHER

Sponsor Role lead

Responsible Party

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Zhaoyun Zhang

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Min He, Doctor

Role: primary

Other Identifiers

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KY2016-360

Identifier Type: -

Identifier Source: org_study_id