Serum Trypsinogen and Lipase As Biomarkers of Exocrine Pancreatic Function in Newly Diagnosed Children and Adolescents with Type 1 Diabetes Mellitus
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ISSN: 2377-3634 Sherif et al. Int J Diabetes Clin Res 2020, 7:118 DOI: 10.23937/2377-3634/1410118 Volume 7 | Issue 1 International Journal of Open Access Diabetes and Clinical Research RESEARCH ARTICLE Serum Trypsinogen and Lipase as Biomarkers of Exocrine Pan- creatic Function in Newly Diagnosed Children and Adolescents with Type 1 Diabetes Mellitus Eman M Sherif, MD1, Doaa M A Elzoghby, MD2 and Rasha Eladawy, MD1* Check for 1Department of Pediatrics, Diabetes Unit, Ain Shams University, Cairo, Egypt updates 2Department of Clinical Pathology, Ain Shams University, Cairo, Egypt *Corresponding author: Rasha Eladawy, MD, Department of Pediatrics, Diabetes Unit, Ain Shams University, Children Hospital, Lotfy Elsayed Street, Abasseya, Cairo, Egypt, Tel: 2010-9214-3033 Abstract Introduction Background: Type 1 diabetes mellitus (T1DM) in literatu- T1DM results from disruption of pancreatic fun- re has usually been associated with laboratory decrease ction as a result of autoimmune destruction of pan- in pancreatic exocrine enzymes levels. Nevertheless, the creatic tissue. The period of development of the au- exact onset of decreased pancreatic enzymes levels in sera of patients is still unknown. We measured pancreatic se- toimmune process and the evidence of overt clinical rum levels of trypsinogen and lipase in Egyptian children picture of DM varies greatly and remains unclear [1]. and adolescents with newly diagnosed T1DM to reveal their However, as the stage of overt clinical type 1 DM is re- role in diagnosis and their relation to HbA1c as a marker ached, associated destruction of the exocrine pancre- of glycemic control, lipid profile and fasting c-peptide as a marker of endocrine pancreatic insufficiency. atic cells usually result in decreased serum pancreatic enzymes such as serum trypsinogen and serum lipase Methods: Fifty Egyptian children with newly diagnosed T1DM were compared to age and sex matched 50 heal- [2,3]. Accordingly, measurement of serum concentra- thy controls. Full clinical history was taken including history tion of pancreatic trypsinogen and/or lipase can be of diabetic ketoacidosis (DKA) and that of pancreatitis. All an early clue for pancreatic disruption. The usage of subjects underwent full clinical examination. Anthropome- pancreatic enzyme; serum trypsinogen and lipase le- tric measurements were taken including weight, height and body mass index. Laboratory data of HbA1c, lipid profile vels as a predictive biomarker of type 1 diabetes has and fasting c-peptide of patients with newly diagnosed been evaluated [2,4]. It is suggested that analysis of T1DM were collected. Serum trypsinogen and serum lipase pancreatic enzymes in diabetic patients could be an were collected from both patients’ and control groups. early marker of disease diagnosis as well as being a Results: Serum trypsinogen and lipase were significantly useful parameter in assessing the progress of illness decreased in patients with newly diagnosed T1DM compa- [1]. To our knowledge, only one study [2] assessed the red with control group (p = 0.00028). There was no rela- tion between the pre-mentioned pancreatic enzymes and level of serum trypsinogen in a mixed group of pedia- fasting c-peptide nor with disease duration (p = 0.42). tric and adults with T1DM and therefore, the current Conclusion: Almost all children and adolescents with newly study assesses the levels of trypsinogen and lipase in diagnosed T1DM had low levels of exocrine pancreatic en- the sera of children and adolescents with newly dia- zymes. Nevertheless, more studies are needed to follow-up gnosed T1DM and the results were correlated to de- both pancreatic enzyme levels as well as exocrine pancre- mographic data, clinical history/examination, HbA1c atic autoantibodies searching for correlations with disease development and progression. and the level of fasting c-peptide. Citation: Sherif EM, Elzoghby DMA, Eladawy R (2020) Serum Trypsinogen and Lipase as Biomarkers of Exocrine Pancreatic Function in Newly Diagnosed Children and Adolescents with Type 1 Diabetes Mellitus. Int J Diabetes Clin Res 7:118. doi.org/10.23937/2377-3634/1410118 Accepted: March 28, 2020: Published: March 30, 2020 Copyright: © 2020 Sherif EM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Sherif et al. Int J Diabetes Clin Res 2020, 7:118 • Page 1 of 5 • DOI: 10.23937/2377-3634/1410118 ISSN: 2377-3634 Subjects and Methods and trypsinogen. Hemolysed samples were discar- ded. Repeated freezing and thawing was avoided. This pilot Study was conducted on one hundred (100) children and adolescents recruited from Chil- HbA1c was assayed by high performance liquid dren's Hospitals, Pediatric department, Faculty of Me- chromatography (HPLC) technique on the Bio-Rad d-10 dicine, Ain Shams University Hospitals, Cairo, Egypt. hemoglobin testing system (Bio-Rad Laboratories, Inc., Patients′ group included fifty (50) children and ado- 4000 Alfred Nobel Drive, Hercules, California 94547, lescents with newly diagnosed T1DM attending the USA). Serum samples were assayed for lipid profile on Pediatric and Adolescents Diabetes Clinic, Ain Shams the Beckman AU-680 system auto-analyzer (Beckman University Hospitals. Coulter, Inc. Diagnostics Division Headquarters 250 Patients diagnosed as T1DM in Diabetes Clinic ac- South Kraemer Boulevard Brea, California 92821-6232 cording to ISPAD diagnostic criteria of diabetes [5]. USA) using reagents supplied by the company. Tri- Also, all patients had low fasting c-peptide levels. All glycerides (TG) and total cholesterol were measured patients included was diagnosed with T1DM within on AU680 is based on enzymatic colorimetric method, 90 days of data collection. Patients’ ages ranged from high density lipoprotein cholesterol (HDL-choleste- two to eighteen years. This study did not include pa- rol) assay was based on precipitation of low density tients with type 2 diabetes mellitus nor other types of lipoprotein cholesterol (LDL-cholesterol) and very low diabetes. Also, patients with gastrointestinal diseases density lipoprotein cholesterol (VLDL-cholesterol) and such as Celiac disease, inflammatory bowel diseases, then the cholesterol in the HDL cholesterol fraction malabsorption syndromes and GIT infections were not which remains in the supernatant is assayed by a ti- included. The control group included fifty (50) age and med endpoint method. LDL cholesterol calculated sex matched healthy children and adolescents. They according to "Friedwald equation": LDL-cholesterol = were recruited from Outpatient Clinic at Ain Shams Total cholesterol-(HDL-C+TG/5), provided that serum University Hospitals. TG is ≤ 400 mg/dL, samples with TG > 400 mg/dL are diluted according to its concentration. Written informed consent was taken from the care givers in ages below 16, and from participants in ages Serum lipase was assayed by lipase quantitative ki- equal or more than sixteen. The procedures applied in netic assay Kit supplied by Biochemical Enterprise (S.r.l. this study were approved by The Ethical Committee of - via Toselli, 4 - 20127 Milano - Italy). Serum trypsinogen Human Experimentation of Ain Shams University, and was assayed by commercially available ELISA kit sup- are in accordance with the Helsinki Declaration. plied by Bioassay Technology Laboratory (1008 Junjiang Inter. Bldg, 228 Ningguo Rd, Yangpu Dist, Shanghai, Chi- Data collected from all patients in the study inclu- na). Fasting serum c-peptide was measured by commer- ded detailed medical history taking with special stress cially available Enzyme Linked Immunosorbent Assay on: Demographic data: Name, age, sex, family history (ELISA) kit supplied by R & D Systems (USA & Canada, of diabetes, disease duration, history of DKA develop- R&D Systems, Inc. 614 McKinley Place NE, Minneapolis, ment, symptoms suggestive of pancreatitis e.g. epiga- MN 55413, USA). stric pain radiating to the back associated with nausea and vomiting and symptoms of pancreatic insufficiency Statistical Analysis e.g. offensive bulky stools, weight loss. All statistical analyses were done using software -ver All subjects included in the study had a thorough full sion IBM SPSS (Statistical Package for the Social Scien- clinical examination laying stress on: Assessment of an- ces) statistics(Version 25.0, IBM Corp., USA, 2017-2018). thropometric measures including weight in Kilograms Data were expressed descriptively as Mean ± standard (Kg) and height in centimeters (cm). Body mass index deviation (SD) for quantitative parametric data, median was calculated as Kg/m2 and plotted on the age -and and interquartile range (IQR) for quantitative non para- sex-standard percentiles according to WHO growth metric values and as percent for qualitative data. Com- charts for weight, height and BMI Z scores [6]. parative statistics were done using Independent Stu- Blood Sampling and Laboratory Analysis dent t test for parametric data and the Mann-Whitney test for non-parametric data. Chi square test was used Under complete aseptic conditions, 10 mL of fa- for comparison between two independent groups as sting venous blood were obtained by a clean veni- regards the categorized data. Correlation analysis was puncture, two milliliters were placed in EDTA tube performed using Pearson′s correlation coefficient for for subsequent assay of HbA1c, while the rest was parametric data