NCT05392166

Prevalence and Factors Associated With Pancreatic Enzyme Elevations Among Diabetic Children

Status unknown NA Last updated 26 May 2022

What this trial tests

NA trial testing blood glucose, blood gases, serum electrolytes, HbA1c, complete blood count and serum creatinine. Serum calcium, serum amylase, serum lipase and serum triglycerides , abdominal ultrasound in Diabetic Children in 100 participants. Status unknown.

Timeline

13 May 2022

Primary endpoint
13 May 2023

13 May 2023

Quick facts

Lead sponsor	Sohag University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	13 May 2022
Primary completion	13 May 2023
Estimated completion	13 May 2023
Sites	1 location across Egypt

Drugs / interventions tested

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

Conditions studied

• Diabetic Children — all drugs for Diabetic Children →

Sponsor

Sohag University

Who can join

Adults 1 Day to 12, any sex, with Diabetic Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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% .

Publications & conference data

No peer-reviewed publications indexed yet for this trial.