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

NCT03309319 | Unknown

• 1 other identifier: KY2016-360
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Tumor

Outcome Measures

Primary Outcomes (3)

• Growth hormone(GH)

  the decrease of growth hormone(GH)

  6 months

• insulin like factor 1(IGF-1)

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

  6 months

• tumor volume

  the change of tumor volume

  6 months

Study Arms (1)

Ros

EXPERIMENTAL

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

Drug: Rosiglitazone

Interventions

Rosiglitazone DRUG

rosiglitazone is added to the primary treatment

Ros

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhaoyun Zhang: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 13, 2017
• Study Start: October 16, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

CN (1)