NCT00174057

Brief Summary

The exact mechanism of the pathogenesis of Graves' ophthalmopathy is still unknown. Histopathologically, extraocular muscle inflammation and orbital fat inflammation are two prominent changes. In the past year, we had investigated the morphological features of the Müller muscle in patients with thyroid lid retraction using the special stain and immunohistochemistry. In our findings, the smooth muscle cells, in the diseased group, were replaced by variable adipose and fibrosis tissues. In recent years, TSHR, has been verified to express in orbital connective tissue and extra-ocular muscle. From functional studies and an increase in adipogenesis in cultured fibroblasts with expression of TSHR protein, the role not only the target but effector cells in orbital fibroblasts were validated. Quantitative RT-PCR may help to differentiate whether a less extent of expression at the end stage or low protein amount to be detected. In recent years, the diverse phenotypes of orbital fibroblasts, with regard to expression of Thy-1 protein or not, had been reported from several studies, the investigators believed heterogeneity in orbital fibroblast may determine the clinical presentation of Graves'ophthalmopathy. We also are curious to know if the phenotypic heterogeneity of the fibroblasts in the ocular adnexal and orbital tissues correlates to distinct morphological features of adipogenesis and fibrosis. Moreover, increased CD40 expression in skin fibroblasts were noted from patients with systemic sclerosis. Expression of IGF-I and IGF-IR seemed to be up-regulated in processes of several fibrotic diseases. A nuclear transcription factor, PPAR-γ, has been verified to have a close relationship with adipogenesis. We hypothesize that some immunological processes involve the ocular adnexal and orbital tissues, which result in various ophthalmological manifestations. The purpose of this study is to investigate the different stage of the ocular adnexal and orbital tissues to identify the pathogenesis of Graves' ophthalmopathy by frozen sections with Immunohistochemistry, mRNA expression of TSH receptor, PPAR-γ, IGF-1R, and IGF-1 and different cytokines using quantitative RT-PCR and flow cytometry at the acute and stable stage in GO.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

September 15, 2005

Status Verified

June 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Keywords

Graves' ophthalmopathyreal time PCRcytokinesTsh receptor

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shu Lang Liao

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Officials

  • Shu Lang Liao, MD

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

August 1, 2005

Study Completion

July 1, 2006

Last Updated

September 15, 2005

Record last verified: 2005-06

Locations