Prevalence and Factors Associated With Pancreatic Enzyme Elevations Among Diabetic Children

NCT05392166 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-26

No results posted yet for this study

Summary

Acute pancreatitis was reported as a DKA associated complication. The true incidence and clinical significance of pancreatitis in children with DKA is unclear. And its diagnosis in children requires a high index of clinical suspicion . Severe hypertriglyceridemia is an uncommon T1D complication which is also due to insulin deficiency and which can trigger acute pancreatitis The triad of DKA, severe hypertriglyceridemia, and acute pancreatitis have been described in children, especially in those with new onset T1D, abdominal pain and vomiting occasionally prompt the measurement of pancreatic enzymes Previous studies indicate that pancreatic enzyme elevations, particularly increased serum lipase levels, are very common in children with DKA. The magnitude of lipase elevation appears to correlate with the degree of acidosis, whereas increased serum amylase level is nonspecific. The majority of patients with elevated enzymes had no significant abdominal symptoms or delay in their clinical recovery. In those with persistent abdominal symptoms after acidosis resolved, abdominal CT findings were normal. The results of previous pediatric studies were comparable to those from studies in adult patients with DKA. Amylase and/or lipase elevations have been reported in 24.7% to 79% of cases. However, the incidence of acute pancreatitis in DKA seems to be higher in adults compared with children and is reported to be more than 10% they also have found that pancreatic enzyme elevations occur much less commonly in the setting of new-onset diabetes without DKA. Consistent with this observation, pancreatic enzymes have been reported to be higher in patients with poorly controlled diabetes compared with those in good control. It was postulated to result from direct injury to the pancreas with enzyme leakage from the acini, secretion of amylase and lipase from non-pancreatic sources, and decreased renal clearance .Acute pancreatitis also is attributed to hypertriglyceridemia.

the diagnosis of Acute Pancreatitis requires 2 of the 3 criteria: (1) abdominal pain not due to other causes, (2) elevated serum lipase or amylase 3 times the upper limit of the normal reference range (ULN), and/or (3) imaging evidence of pancreatitis . But also, there are limitations associated with each criterion in children . Although abdominal pain is the most common presentation, up to one third of patients may not report abdominal pain and radiation of pain to the back occurs in5% .

Conditions

  • Diabetic Children

Interventions

DIAGNOSTIC_TEST

blood glucose, blood gases, serum electrolytes, HbA1c, complete blood count and serum creatinine. Serum calcium, serum amylase, serum lipase and serum triglycerides , abdominal ultrasound

blood samples will be collected at admission for assessment of blood glucose, blood gases, serum electrolytes, HbA1c, complete blood count and serum creatinine. Serum calcium, serum amylase, serum lipase and serum triglycerides will be assessed within the first 24 hours after hospital admission. For the control group, the blood samples will be collected during the pediatric diabetes clinic follow-up visits. Abdominal ultrasound will be done to all the study participants.

Sponsors & Collaborators

  • Sohag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2023-05-13
Completion
2023-05-13

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392166 on ClinicalTrials.gov