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

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ClinicalTrials.gov Identifier: NCT03309319
Recruitment Status : Unknown
Verified October 2017 by Zhaoyun Zhang, Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Zhaoyun Zhang, Huashan Hospital

Study Description
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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
Allocation: N/A
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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Growth hormone(GH) [ Time Frame: 6 months ]
    the decrease of growth hormone(GH)

  2. insulin like factor 1(IGF-1) [ Time Frame: 6 months ]
    the decrease of insulin like factor 1(IGF-1)

  3. 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    
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 Neoplasms
Growth Hormone-Secreting Pituitary Adenoma
Pituitary Diseases
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