- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03324334
Prevalence of Graves Disease in Patients With Ulcerative Colitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Patients with diabetes mellitus.
- patients with a diagnosis of other than ulcerative colitis
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Patients with ulcerative colitis Interventions to be administered: Thyroid antibodies and Thyroid sonography
|
Thyroid antibodies: Antithyroperoxidase(Anti-TPO), Anti-thyroglobulin (anti-TG) to detect graves disease in study and control groups
Thyroid sonography to detect anatomical changes in thyroid
|
|
Control group
normal control subjects selected from general population at random Interventions to be administered: Thyroid antibodies and Thyroid sonography
|
Thyroid antibodies: Antithyroperoxidase(Anti-TPO), Anti-thyroglobulin (anti-TG) to detect graves disease in study and control groups
Thyroid sonography to detect anatomical changes in thyroid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients with graves disease in ulcerative colitis
Time Frame: In 2 days
|
By use of thyroid antibodies and thyroid sonography
|
In 2 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alaa K Hussein, MD, Assiut University,Faculty Of medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Endocrine System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Thyroid Diseases
- Colonic Diseases
- Intestinal Diseases
- Exophthalmos
- Orbital Diseases
- Goiter
- Hyperthyroidism
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Graves Disease
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
Other Study ID Numbers
- PGDUC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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