Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Graves Disease in Patients With Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03324334
Recruitment Status : Unknown
Verified October 2017 by Alaa Khaleel, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Alaa Khaleel, Assiut University

Brief 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. 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.


Condition or disease Intervention/treatment
Ulcerative Colitis Diagnostic Test: Thyroid antibodies Diagnostic Test: Thyroid sonography

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 95 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Prevalence of Graves Disease in Patients With Ulcerative Colitis
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study group
Patients with ulcerative colitis Interventions to be administered: Thyroid antibodies and Thyroid sonography
Diagnostic Test: Thyroid antibodies
Thyroid antibodies: Antithyroperoxidase(Anti-TPO), Anti-thyroglobulin (anti-TG) to detect graves disease in study and control groups

Diagnostic Test: Thyroid sonography
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
Diagnostic Test: Thyroid antibodies
Thyroid antibodies: Antithyroperoxidase(Anti-TPO), Anti-thyroglobulin (anti-TG) to detect graves disease in study and control groups

Diagnostic Test: Thyroid sonography
Thyroid sonography to detect anatomical changes in thyroid




Primary Outcome Measures :
  1. Percentage of patients with graves disease in ulcerative colitis [ Time Frame: In 2 days ]
    By use of thyroid antibodies and thyroid sonography



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324334


Contacts
Layout table for location contacts
Contact: Hussein A Elamin, Prof doctor 01004084187 Elamin67@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Principal Investigator: Alaa K Hussein, MD Assiut University,Faculty Of medicine

Publications:
Layout table for additonal information
Responsible Party: Alaa Khaleel, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03324334     History of Changes
Other Study ID Numbers: PGDUC
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Graves Disease
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs