Ulcerative ColitisNCT03324334
Prevalence of Graves Disease in Patients With Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Assiut University.
Trial summary
Graves disease in ulcerative colitis: The connection between Graves disease and Inflammatory bowel disease is well known in the literature, but thyroid disorders have not been considered extra-intestinal manifestations of ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Thyroid antibodies and Thyroid sonography
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: seventy five patients who are diagnosed with ulcerative colitis who were admitted to Internal medicine department and who attend outpatient clinics in Assuit University Hospital will be involved in this study compared with 20 normal control subjects selected from general population at random
Who may be able to join
- 1. seventy five patients who are diagnosed with ulcerative colitis who were admitted to Internal medicine department and who attend outpatient clinics in Assiut University Hospital will be involved in this study
Who cannot join
- Patients with diabetes mellitus.
- patients with a diagnosis of other than ulcerative colitis
Trial locations and contacts
No sites are listed yet.
About this study
Graves disease in ulcerative colitis:
The connection between Graves disease and Inflammatory bowel disease is well known in the literature, but thyroid disorders have not been considered extra-intestinal manifestations of ulcerative colitis. In most cases, the diagnosis of thyroid disease has preceded that of Inflammatory bowel disease. Early studies have suggested a relationship between thyroid abnormalities and ulcerative colitis . But it is still uncertain whether the coexistence of Grave's and ulcerative colitis diseases is due to a specific reason or a coincidence.
Read the detailed description
Graves disease in ulcerative colitis:
The connection between Graves disease and Inflammatory bowel disease is well known in the literature, but thyroid disorders have not been considered extra-intestinal manifestations of ulcerative colitis. In most cases, the diagnosis of thyroid disease has preceded that of Inflammatory bowel disease . Early studies have suggested a relationship between thyroid abnormalities and ulcerative colitis .But it is still uncertain whether the coexistence of Grave's and ulcerative colitis diseases is due to a specific reason or a coincidence.
Concomitant Graves disease and ulcerative colitis; In general, the pathophysiology of ulcerative colitis is associated with theTh2 cytokine phenotype, and there is increased Th2 activity in Graves disease .Therefore, both Graves disease and ulcerative colitis are associated with a Th1/Th2 imbalance, with a dominance of Th2 responses. reported on a 26-year-old female who had a flare-up of ulcerative colitis and hyperthyroidism that was successfully treated with infliximab. In addition, they reported that theTh1/Th2 imbalance was improved 2 weeks after the initiation of infliximab therapy. However, it is still unclear whether Graves disease is an extra intestinal manifestation of ulcerative colitis or not Restricted to ulcerative colitis only, we found OR significantly increased for Grave's disease.
Increasing evidence suggests that Grave's disease (GD), an autoimmune thyroid disease (AITD) that accounts for 60%-80% of hyperthyroidism cases, might be related to the abnormal genetic expressions, imbalance of immune responses, increased Th2 activity and overgrowth of intestinal bacteria. For instance, the prior literature showed that some genetic factors, such as Human leukocytic antigen , PTPN22 and CTLA4, were associated with Graves disease Other studies also observed that hyperthyroidism with autoimmune gastritis is usually accompanied with low acid production that may subsequently lead to an overgrowth of intestinal bacteria Therefore, it is plausible that hyperthyroidism might be one of the potential risk factors for ulcerative colitis, because both ulcerative colitis and hyperthyroidism are polygenic diseases and may share analogous mechanisms Furthermore, genetic pathways and Th2-dominant immunological responses could contribute to the association between ulcerative colitis and hyperthyroidism.
- Conditions
- Ulcerative Colitis
- Being tested
- Thyroid antibodies, Thyroid sonography
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid antibodiesDiagnostic test
Thyroid antibodies: Antithyroperoxidase(Anti-TPO), Anti-thyroglobulin (anti-TG) to detect graves disease in study and control groups
Thyroid sonographyDiagnostic test
Thyroid sonography to detect anatomical changes in thyroid
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with ulcerative colitis Interventions to be administered: Thyroid antibodies and Thyroid sonography Receives: Diagnostic Test: Thyroid antibodies; Diagnostic Test: Thyroid sonography | |
| Control group | normal control subjects selected from general population at random Interventions to be administered: Thyroid antibodies and Thyroid sonography Receives: Diagnostic Test: Thyroid antibodies; Diagnostic Test: Thyroid sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with graves disease in ulcerative colitis
By use of thyroid antibodies and thyroid sonography
Measured: In 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Khaleel, Assiut University
- Investigators
- Alaa K Hussein, MD, Principal investigator, Assiut University,Faculty Of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324334
- Sponsor's protocol ID
- PGDUC
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shizuma T. Concomitant Thyroid Disorders and Inflammatory Bowel Disease: A Literature Review. Biomed Res Int. 2016;2016:5187061. doi: 10.1155/2016/5187061. Epub 2016 Mar 3.
PubMed 27042663
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Graves Disease in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03324334
- Acronym / sponsor ID
- PGDUC
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Graves disease in ulcerative colitis:
The connection between Graves disease and Inflammatory bowel disease is well known in the literature, but thyroid disorders have not been considered extra-intestinal manifestations of ulcerative colitis. In most cases, the diagnosis of thyroid disease has preceded that of Inflammatory bowel disease. Early studies have suggested a relationship between thyroid abnormalities and ulcerative colitis . But it is still uncertain whether the coexistence of Grave's and ulcerative colitis diseases is due to a specific reason or a coincidence.
Detailed description
Graves disease in ulcerative colitis:
The connection between Graves disease and Inflammatory bowel disease is well known in the literature, but thyroid disorders have not been considered extra-intestinal manifestations of ulcerative colitis. In most cases, the diagnosis of thyroid disease has preceded that of Inflammatory bowel disease . Early studies have suggested a relationship between thyroid abnormalities and ulcerative colitis .But it is still uncertain whether the coexistence of Grave's and ulcerative colitis diseases is due to a specific reason or a coincidence.
Concomitant Graves disease and ulcerative colitis; In general, the pathophysiology of ulcerative colitis is associated with theTh2 cytokine phenotype, and there is increased Th2 activity in Graves disease .Therefore, both Graves disease and ulcerative colitis are associated with a Th1/Th2 imbalance, with a dominance of Th2 responses. reported on a 26-year-old female who had a flare-up of ulcerative colitis and hyperthyroidism that was successfully treated with infliximab. In addition, they reported that theTh1/Th2 imbalance was improved 2 weeks after the initiation of infliximab therapy. However, it is still unclear whether Graves disease is an extra intestinal manifestation of ulcerative colitis or not Restricted to ulcerative colitis only, we found OR significantly increased for Grave's disease.
Increasing evidence suggests that Grave's disease (GD), an autoimmune thyroid disease (AITD) that accounts for 60%-80% of hyperthyroidism cases, might be related to the abnormal genetic expressions, imbalance of immune responses, increased Th2 activity and overgrowth of intestinal bacteria. For instance, the prior literature showed that some genetic factors, such as Human leukocytic antigen , PTPN22 and CTLA4, were associated with Graves disease Other studies also observed that hyperthyroidism with autoimmune gastritis is usually accompanied with low acid production that may subsequently lead to an overgrowth of intestinal bacteria Therefore, it is plausible that hyperthyroidism might be one of the potential risk factors for ulcerative colitis, because both ulcerative colitis and hyperthyroidism are polygenic diseases and may share analogous mechanisms Furthermore, genetic pathways and Th2-dominant immunological responses could contribute to the association between ulcerative colitis and hyperthyroidism.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Thyroid antibodies, Diagnostic Test: Thyroid sonographyPatients with ulcerative colitis Interventions to be administered: Thyroid antibodies and Thyroid sonography |
| Control group | – | Diagnostic Test: Thyroid antibodies, Diagnostic Test: Thyroid sonographynormal control subjects selected from general population at random Interventions to be administered: Thyroid antibodies and Thyroid sonography |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- seventy five patients who are diagnosed with ulcerative colitis who were admitted to Internal medicine department and who attend outpatient clinics in Assuit University Hospital will be involved in this study compared with 20 normal control subjects selected from general population at random
Key inclusion criteria (1 listed)
- 1. seventy five patients who are diagnosed with ulcerative colitis who were admitted to Internal medicine department and who attend outpatient clinics in Assiut University Hospital will be involved in this study
Key exclusion criteria (2 listed)
- Patients with diabetes mellitus.
- patients with a diagnosis of other than ulcerative colitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyroid antibodiesThyroid antibodies: Antithyroperoxidase(Anti-TPO), Anti-thyroglobulin (anti-TG) to detect graves disease in study and control groups | Diagnostic test | Control group, Study group |
| Thyroid sonographyThyroid sonography to detect anatomical changes in thyroid | Diagnostic test | Control group, Study group |
Primary outcome
Percentage of patients with graves disease in ulcerative colitis
Time frame: In 2 days
By use of thyroid antibodies and thyroid sonography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Background: PubMed 27042663Shizuma T. Concomitant Thyroid Disorders and Inflammatory Bowel Disease: A Literature Review. Biomed Res Int. 2016;2016:5187061. doi: 10.1155/2016/5187061. Epub 2016 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa K Hussein, MD principal investigator
Assiut University,Faculty Of medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussein A Elamin, Prof doctor (01004084187, Elamin67@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with graves disease in ulcerative colitis (time frame: In 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03324334, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.