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

• Sponsor: Zhaoyun Zhang (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03309319
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 26.5
• Patients Per Site Per Month: 0.9

Study Details

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 16, 2016
• Anticipated Primary Completion Date: Dec 31, 2018
• Anticipated Study Completion Date: Dec 31, 2018

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

1. Growth hormone(GH) [6 months]

   the decrease of growth hormone(GH)

2. insulin like factor 1(IGF-1) [6 months]

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

3. tumor volume [6 months]

   the change of tumor volume

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

• Zhaoyun Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhaoyun Zhang, professor, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT03309319
• Other Study ID Numbers: KY2016-360
• First Posted: Oct 13, 2017
• Last Update Posted: Oct 13, 2017
• Last Verified: Oct 1, 2017

• Additional relevant MeSH terms: Adenoma; Pituitary Neoplasms; Growth Hormone-Secreting Pituitary Adenoma; Pituitary Diseases; Rosiglitazone

Study Results

No Results Posted as of Oct 13, 2017