Prevalence of Graves Disease in Patients With Ulcerative Colitis

October 26, 2017 updated by: Alaa Khaleel, Assiut University

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

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

Observational

Enrollment (Anticipated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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:

  1. Patients with diabetes mellitus.
  2. patients with a diagnosis of other than ulcerative colitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Alaa K Hussein, MD, Assiut University,Faculty Of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

February 28, 2019

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 26, 2017

First Posted (Actual)

October 27, 2017

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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