- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03666117
Prevalence of Hepatomegaly in Children and Adolescents With Type 1 Diabetes Mellitus
Prevalence of Hepatomegaly in Children and Adolescents With Type 1 Diabetes Mellitus Attending Assiut University Children Hospital
Study Overview
Status
Conditions
Detailed Description
Type 1 diabetes is a disorder of glucose metabolism that results from insulin deficiency secondary to autoimmune destruction of insulin-secreting β-cells. The prevalence of liver disease among diabetics is estimated to be between 17% and 100%(1).
Most of these data were obtained from studies of obese adults with non-insulin dependent diabetes(2). Data regarding frequency of aetiological causes of hepatomegaly in children and adolescent with type 1 diabetes mellitus are scanty even in international publication(2).
Diabetes mellitus (DM) is associated with various structural and functional liver abnormalities, including non-alcoholic fatty liver disease (NAFLD) and hepatic glycogenosis (HG)(3).
NAFLD represents the most common liver disease(3) and is more typically found in obese adults with T2DM secondary to insulin resistance, while (HG) is more common in patients with lower body mass index and pediatric patients(4).
HG involves pathological glycogen storage in hepatocytes and is characterized by hepatomegaly and a transient elevation in liver transaminases that is associated with poorly controlled DM, particularly type 1 diabetes (T1D)(5).
The differential diagnosis of hepatomegaly in diabetic patients must consider several other potential causes of liver damage, such as infection (e.g., viral hepatitis), metabolic disorders (e.g., α1-antitrypsin deficiency and Wilson's disease), obstruction, autoimmune liver disease, hemochromatosis and celiac disease(6).
Presence of hepatomegaly and/or hyperechogenic liver on ultrasound abdomen was an indication for further laboratory work up to investigate other possible liver pathologies .The screening work up included: HBV surface antigen, Anti-HCV antibody, serum immunoglobulins, anti-nuclear antibody, smooth muscle antibody qualitative test , serum ferritin, serum iron, transferring saturation, and total iron binding capacity, urine for organic acids and plasma for amino acids, to evaluate for possibility of viral hepatitis B and C, autoimmune liver disease, hemochromatosis, and metabolic disorder, respectively(7).
It was considered that the finding of hyperechogenic liver and/or hepatomegaly on ultrasound and negative screening work up for underlying liver disease as consistent with a likely diagnosis of hepatic glycogenosis or less likely fatty liver(8).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Assiut, Egypt, 17100551
- Assiut children hospital
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Contact:
- Manar Khalifa, Resident
- Phone Number: 01127670977
- Email: ma.peddr450@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with type 1 Diabetes mellitus diagnosed according to the diagnostic criteria of the American Diabetes Association 2011.
Exclusion Criteria:
- 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).
4- Syndromic children. 5-Patients known to have liver disease prior to diagnosis of diabetes.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Study group
children and adolescents with type 1 diabetes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Hepatomegaly in children and adolescents
Time Frame: 1 year
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the prevalence of different causes of hepatomegaly with type 1 diabetes mellitus .
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1 year
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Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- 17100551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Analytic Code
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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