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临床试验/NCT05392166
NCT05392166Unknown不适用

Prevalence and Factors Associated With Pancreatic Enzyme Elevations Among Children With Type 1 Diabetes Hospitalized With Diabetic Ketoacidosis

Sohag University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
pancreatic enzymes elevation in diabetic children .

研究概览

简要总结

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% .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Day 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 0-12 years, diagnosed with type 1 diabetes mellitus and admitted to the pediatric emergency department with DKA criteria including, Blood glucose level > 200 mg/dl, pH < 7.3, and /or bicarbonate level in blood < 15 mmol/l and positive ketones in urine by dipstick method, will be included. Age, sex and duration of diabetes matched control children without DKA will be recruited from T1DM children attending the pediatric diabetes clinic at Sohag university hospital.

排除标准

  • Patients diagnosed with congenital or acquired chronic pancreatitis or gall stones will be excluded.

结局指标

主要结局

pancreatic enzymes elevation in diabetic children .

时间窗: 1year

assesment of level of serum amylase and serum lipase within 24 hours of admission

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walaa Saber Kassem

resident doctor at pediatric department at faculty of medicine sohag university hospital

Sohag University

研究点 (1)

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