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

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ClinicalTrials.gov Identifier: NCT03309319

Recruitment Status : Recruiting

First Posted : October 13, 2017

Last Update Posted : October 13, 2017

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Zhaoyun Zhang, Huashan Hospital

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.

Condition or disease	Intervention/treatment	Phase
Pituitary Tumor	Drug: Rosiglitazone	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	24 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas
Actual Study Start Date :	October 16, 2016
Estimated Primary Completion Date :	December 31, 2018
Estimated Study Completion Date :	December 31, 2018

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Familial isolated pituitary adenoma

MedlinePlus related topics: Pituitary Disorders Pituitary Tumors

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ros Rosiglitazone：2 times a day, 4mg each time（4mgBid）	Drug: Rosiglitazone rosiglitazone is added to the primary treatment

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309319

Locations

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China, Shanghai
Huashan Hospital	Recruiting
Shanghai, Shanghai, China, 200040
Contact: Min He, Doctor +862152887027 mhe2004@263.net
Principal Investigator: Zhaoyun Zhang, Professor

Sponsors and Collaborators

Zhaoyun Zhang

More Information

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Responsible Party:	Zhaoyun Zhang, professor, Huashan Hospital
ClinicalTrials.gov Identifier:	NCT03309319 History of Changes
Other Study ID Numbers:	KY2016-360
First Posted:	October 13, 2017 Key Record Dates
Last Update Posted:	October 13, 2017
Last Verified:	October 2017

Additional relevant MeSH terms:

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Adenoma Pituitary Diseases Pituitary Neoplasms Growth Hormone-Secreting Pituitary Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases	Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Hypothalamic Neoplasms Supratentorial Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs

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