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Prevalence of Hepatomegaly in Children and Adolescents With Type 1 Diabetes Mellitus

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03666117
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Information provided by (Responsible Party):
Manar Khalifa Zohery Shazly, Assiut University

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.

Condition or disease

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).

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Hepatomegaly in Children and Adolescents With Type 1 Diabetes Mellitus Attending Assiut University Children Hospital
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Study group
children and adolescents with type 1 diabetes

Primary Outcome Measures :
  1. Prevalence of Hepatomegaly in children and adolescents [ Time Frame: 1 year ]
    the prevalence of different causes of hepatomegaly with type 1 diabetes mellitus .

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children and adolescents

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.

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 identifier (NCT number): NCT03666117

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Assiut children hospital Recruiting
Assiut, Egypt, 17100551
Contact: Manar Khalifa, Resident    01127670977   
Sponsors and Collaborators
Assiut University

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Responsible Party: Manar Khalifa Zohery Shazly, Seed pharmaceutical company street, Assiut University Identifier: NCT03666117     History of Changes
Other Study ID Numbers: 17100551
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Analytic Code
Time Frame: 1 year

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Liver Diseases
Digestive System Diseases
Pathological Conditions, Anatomical