Plain English Summary
Background and study aims
Thyroid-associated ophthalmopathy (TAO) is an autoimmune process that affects the orbital and periorbital tissue (the area around the eye), and the thyroid. It can cause eyelids to retract, proptosis (protusion or displacement of the eye), chemosis (swelling of the lines inside the eye), edma (swelling) around the eye and has social and cosmetic consequences. It does not usually cause vision loss but can threaten vision. Insulin-like growth factor 1 (IGF-1), a hormone that is similar to insulin, could play a role in TAO. Earlier studies have shown that there was no difference between IGF-1 levels in patients with severe TAO but this research only used a small sample of patients, therefore a larger study would be helpful in determining the role of IGF-1. The aim of this study is to determine the role of insulin-like growth factor 1 (IGF01) in the development of thyroid associated ophthalmopathy.
Who can participate?
Adults aged 18 and older who have thyroid associated ophthalmopathy
What does the study involve?
Participants provide blood samples. While they are undergoing their normally scheduled surgery, orbital samples from the surgical waste are taken. The IGF-1 in serum levels and the IGF-1 concentration in the orbital fibroblasts are analysed using the Enzyme-linked immunosorbent assay (ELISA) kit and are compared. There is no further follow up for participants.
What are the possible benefits and risks of participating?
Participants may benefit from being notified of the results of their blood test. There no notable minimal risks of donating orbital tissues. Participants may feel discomfort when giving blood samples.
Where is the study run from?
Peking Union Medical College Hospital (China)
When is the study starting and how long is it expected to run for?
January 2010 to January 2011
Who is funding the study?
Peking Union Medical College Hospital and State Scholarship Fund (China)
Who is the main contact?
Dr Yong Zhong
yzhong.pumch@gmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
To determine the correlation between clinical activity scores of patients with thyroid associated ophthalmopathy (TAO) and their locally produced and / or systemically circulated insulin-like growth factor 1 (IGF-1): a single-centre case-controlled study
Acronym
Study hypothesis
Earlier study showed no difference between IGF-1 serum levels of severe TAO patients, but due to the limited number of TAO patients recruited in this study, we want to repeat this study with more TAO patients involved in. In addition, we hypothesise that the IGF-1 produced locally around orbit is independently from systemically circulated IGF-1. To accomplish this, we need the orbital tissue from TAO patients to culture the orbital fibroblast in order to investigate its secretion effect of IGF-1.
Ethics approval
Ethical Committee Board of the Peking Union Medical College Hospital approved on 03/01/2010
Study design
Single-centre case-controlled study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Thyroid associated ophthalmopathy
Intervention
The IGF-1 in serum levels and IGF-1 concentration in culture media of orbital fibroblasts were determined by an Enzyme-linked immunosorbent assay (ELISA) kit. No follow up after the sample collection.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
No correlation was found between levels of either total or free IGF-1 in serum with clinical activity score (CAS) of TAO patients, but the IGF-1 in culture medium of orbital fibroblast from TAO patients positively correlated with CAS.
Secondary outcome measures
The IGF-1 level in culture medium of orbital fibroblast, determined by a commercial enzyme linked immunosorbent assay ELISA kit, after 48hr in culture.
Overall trial start date
03/01/2010
Overall trial end date
03/01/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. TAO patients and healthy controls above 18-year old, either sex
2. Body mass index (BMI) (18.5-25 kg/m2)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Around 20 TAO patients and normal donors for blood collection, 5 TAO paitents and healthy controls orbital tissue collection.
Participant exclusion criteria
Individuals with:
1. Non-thyroid autoimmune diseases
2. Asthma
3. Granulomatous disease
4. Sinusitis
5. Human immunodeficiency virus (HIV) infection
6. Pregnancy
7. Undercurrent illness
Recruitment start date
03/01/2010
Recruitment end date
03/01/2011
Locations
Countries of recruitment
China
Trial participating centre
1 Shuaifuyuan
Beijing
100730
China
Funders
Funder type
Government
Funder name
China Scholarship Council (China) - State Scholarship Fund (File No. 2010621116)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Peking Union Medical College Hospital (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list