Condition category
Eye Diseases
Date applied
03/08/2011
Date assigned
16/08/2011
Last edited
08/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Yong Zhong

ORCID ID

Contact details

1 Shuaifuyuan
Dongdan
Dongcheng District
Beijing
100730
China

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 measures

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

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

Sponsor information

Organisation

Peking Union Medical College Hospital (China)

Sponsor details

1 Shuaifuyuan
Dongdan
Dongcheng District
Beijing
100730
China

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/05/2017: Plain English Summary added.