NCT03324334

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

October 24, 2017

Last Update Submit

October 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with graves disease in ulcerative colitis

    By use of thyroid antibodies and thyroid sonography

    In 2 days

Study Arms (2)

Study group

Patients with ulcerative colitis Interventions to be administered: Thyroid antibodies and Thyroid sonography

Diagnostic Test: Thyroid antibodiesDiagnostic Test: Thyroid sonography

Control group

normal control subjects selected from general population at random Interventions to be administered: Thyroid antibodies and Thyroid sonography

Diagnostic Test: Thyroid antibodiesDiagnostic Test: Thyroid sonography

Interventions

Thyroid antibodiesDIAGNOSTIC_TEST

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

Control groupStudy group
Thyroid sonographyDIAGNOSTIC_TEST

Thyroid sonography to detect anatomical changes in thyroid

Control groupStudy group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \. 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27042663BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Alaa K Hussein, MD

    Assiut University,Faculty Of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hussein A Elamin, Prof doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 27, 2017

Study Start

November 1, 2017

Primary Completion

October 1, 2018

Study Completion

February 28, 2019

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share