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Synbiotic supplementation in type one diabetes mellitus: A Randomized Controlled Clinical Trial

Document Type : original article

Authors

1 Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.

2 Pediatric Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran

3 Department of clinical pharmacy, Faculty of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran

4 1. Student Research Committee, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran 2. Student research committee, Virtual School of Medical Education and Management, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

5 Department of Nutrition, Science and Research Branch, Islamic Azad University, Tehran, Iran.

Abstract

Background: limited studies have been conducted on the effect of synbiotics supplementation on Type 1 Diabetes Mellitus (T1DM). The current study aimed to evaluate the impacts of synbiotic supplementation on glycemic parameters, lipid profile, and vitamin D levels in children with T1DM.
Methods: In this double-blind, randomized controlled trial, 86 T1DM patients aged 4-18 were randomly divided into two equal groups. One group received insulin and a synbiotic supplement once daily for 12 weeks; another group received insulin and a placebo. FBS (fasting blood sugar), HbA1C (hemoglobin A1c), triglycerides, cholesterol, HDL (High-density lipoprotein), LDL (low-density lipoprotein), and vitamin D levels were measured at the beginning and end of the study in both groups.
Results: The trend of FBS, HbA1C, triglycerides, cholesterol, HDL, LDL, and vitamin D changes was not significant over time in both groups. Based on the analysis of covariance, the means of FBS and HbA1C were lower in the intervention group (p=0.048 and 0.025, respectively). However, no significant changes in triglycerides, cholesterol, HDL, LDL, and vitamin D levels were observed between the two groups (p= 0.291, 0.291, 0.952, 0.140, and 0.557, respectively).
Conclusion: It's suggested that insulin treatment in combination with synbiotic supplementation could improve FBS and HbA1C in T1DM children but had no effects on lipid profile and vitamin D levels.

Keywords

References
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International Journal of Pediatrics
Volume 11, Issue 7
July 2023
Pages 18044-18054
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