NCT03666117

Brief Summary

To assess the prevalence of hepatomegaly in children and adolescents with type 1 diabetes mellitus, and to find out it᾿s underlying etiology.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 9, 2018

Last Update Submit

September 10, 2018

Conditions

Hepatomegaly

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Hepatomegaly in children and adolescents

    the prevalence of different causes of hepatomegaly with type 1 diabetes mellitus .

    1 year

Study Arms (1)

Study group

children and adolescents with type 1 diabetes

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

children and adolescents

You may qualify if:

  • Patients with type 1 Diabetes mellitus diagnosed according to the diagnostic criteria of the American Diabetes Association 2011.

You may not qualify if:

  • \- 1-Patients with type 2 diabetes mellitus 2-Patients with secondary diabetes 3-Patients with type 1 diabetes mellitus with other system affection rather than hepatic affection like ( Central nervous system, Respiratory, Renal, Cardiovascular).
  • Syndromic children. 5-Patients known to have liver disease prior to diagnosis of diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut children hospital

Asyut, 17100551, Egypt

Location

MeSH Terms

Conditions

Hepatomegaly

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seed pharmaceutical company street

Study Record Dates

First Submitted

September 9, 2018

First Posted

September 11, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share
Shared Documents
ANALYTIC CODE
Time Frame
1 year

Locations

EG(1)