Clinical trial NCT03666117: Prevalence of Hepatomegaly in Children and Adolescents With Type 1 Diabetes Mellitus
Official title: Prevalence of Hepatomegaly in Children and Adolescents With Type 1 Diabetes Mellitus Attending Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatomegaly
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children and adolescents

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Hepatomegaly in children and adolescents
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut children hospital
Study officials:
References: