The effect of squalene on proteinuria in patients with type 2 diabetes mellitus

Background: Squalene, in recent years, has become a topic of interest to scientists due to its potential health benefits and anti-inflammatory effects. Squalene is a hydrocarbon belonging to the triterpene class; it is a 30-carbon isoprenoid compound. In previous studies, amaranth oil, containing high amounts of squalene, was shown to function as an effective treatment option for reducing proteinuria, one of the key markers for renal disease. Objectives: Our main goal was to understand the effect of squalene as a biotic agent for reducing proteinuria. In order to identify squalene as the decreasing agent of proteinuria in amaranth oil, we conducted an experimental study on diabetic patients. Our research focused on patients with type 2 diabetes mellitus with separate dosages of squalene serum consumption. Over the course of 84 days, we tracked changes in proteinuria levels based on the dosage of squalene consumed. In addition to this, testing was also conducted for 84 days on various related parameters. These parameters include blood urea nitrogen (BUN), cystatin C, albumin, systolic and diastolic blood pressure, and transforming growth factor b1 (TGFB1). By assessing changes throughout the study, we hoped to analyze the relationship between proteinuria and these associated parameters.Methods: Five groups of 30 people, totaling 150 volunteers, were recruited into the study. In group 1, 30 healthy people served as the healthy group. In group 2, 30 T2DM patients did not consume any squalene, thereby serving as the diabetic control group. Group 3 consisted of 30 T2DM patients who consumed 200 mg of squalene (extracted from shark liver) daily. Group 4 consisted of 30 T2DM patients who consumed 400 mg of squalene daily. Lastly, group 5 consisted of 30 T2DM patients who consumed 600 mg of squalene daily. In groups 3, 4, and 5, the patients were prescribed to consume squalene for a total of 84 consecutive days. Among the patients with type 2 diabetes referred to Vali-Asr medical laboratory (Tehran, Iran), 120 were selected. Also, 30 people participated in the study as healthy individuals. Regarding World Health Organization, inclusion criteria included the following: fasting plasma glucose amounts ≥ 126 mg/dL, glycated hemoglobin (HbA1c) ≥ 6.5%, and not taking corticosteroids. Informed consent was obtained from all volunteers. Results: Throughout these 84 days, proteinuria levels decreased in these patients with high statistical significance. A positive correlation was also observed with dosage amount, as there had been a higher level of decrease in proteinuria amount with a higher dosage of squalene serum administered for consumption. Statistical significance was found in proteinuria as well as the associated parameters tested (BUN, Albumin (AL), creatinine (CR), cystatin C, and TGFbeta1. Conclusion: All of the associated health indicative parameters we tested alongside proteinuria count also showed a trend of overall reduction throughout the duration of 84 days. These values vary based on the dosage of squalene consumed as well as the time elapsed from the initial prescription. Based on these results, it may be assumed that squalene functions effectively to reduce all of these parameters as well as overall proteinuria level.Keywords: Squalene, proteinuria, renal disease, diabetes, functional food, amaranth oil