PMID- 38001474 OWN - NLM STAT- MEDLINE DCOM- 20231201 LR - 20231201 IS - 1472-6823 (Electronic) IS - 1472-6823 (Linking) VI - 23 IP - 1 DP - 2023 Nov 25 TI - Effect of coadministration of omega-3 fatty acids with glimepiride on glycemic control, lipid profile, irisin, and sirtuin-1 in type 2 diabetes mellitus patients: a randomized controlled trial. PG - 259 LID - 10.1186/s12902-023-01511-2 [doi] LID - 259 AB - BACKGROUND AND OBJECTIVE: Type 2 diabetes mellitus (T2DM) is caused by insulin resistance or tissue insensitivity to insulin, as well as relative insulin insufficiency. Diabetes that is uncontrolled for an extended period of time is linked to substantial comorbidities and organ damage. The purpose of the current study is to assess the effect of coadministration of omega-3 fatty acids with glimepiride on blood glucose, lipid profile, serum irisin, and sirtuin-1 levels in T2DM patients. METHODS: This clinical trial involved 70 type 2 diabetic patients randomly assigned to glimepiride 3 mg with either omega-3 capsules contained fish oil 1000 mg, 13% of eicosapentaenoic acid (EPA) and 9% docosahexaenoic acid (DHA) (omega-3 group, n = 35) or placebo capsules contained corn oil and linoleic acid (control group, n = 35) daily for three months. Blood samples were obtained at the start of the study and 12 weeks later for biochemical examination of HbA1c%, FBG, fasting insulin, and lipid profile. In addition, the atherogenic index of plasma (AIP) was calculated. Human enzyme-linked immunosorbent assay (ELISA) kits were utilized for assessing serum irisin and sirtuin-1 levels before and after the intervention. RESULTS: Compared to the control group, omega-3 fatty acids decreased serum fasting blood glucose (FBG, p < 0.001), glycated hemoglobin percent (HbA1C%, p < 0.001), total cholesterol (TC, p < 0.001), triglycerides (TGs, p = 0.006), low density lipoprotein (LDL, p = 0.089), and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR, p = 0.021) after three months of intervention. However, a significant increase was reported in serum irisin and high density lipoprotein (HDL) between both groups after intervention (p = 0.026 and p = 0.007, respectively). The atherogenic index of plasma (AIP) increased in the control group but decreased in the omega-3 group, with significant differences between the two groups (p < 0.001). CONCLUSION: The present study found that supplementing with omega-3 fatty acids might dramatically enhance blood irisin levels, as well as improve glycemic control and lipid profile in type 2 diabetes mellitus patients using glimepiride. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov under identifier NCT03917940 . (The registration date: April 17, 2019). CI - (c) 2023. The Author(s). FAU - Werida, Rehab H AU - Werida RH AUID- ORCID: 0000-0002-5983-3993 AD - Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, Damanhour University, Damanhour, 22514, Egypt. rehabwrieda@pharm.dmu.edu.eg. FAU - Ramzy, Aalaa AU - Ramzy A AD - Ministry of Health and Population, Damanhour City, Egypt. FAU - Ebrahim, Youssri Nassief AU - Ebrahim YN AD - Internal Medicine and Diabetes Department, Damanhour Medical National Institute, Damanhour City, Egypt. FAU - Helmy, Maged Wasfy AU - Helmy MW AD - Pharmacology and Toxicology, Faculty of Pharmacy, Damanhour University, Damanhour, 22514, Egypt. AD - Pharmacology and Toxicology, College of Pharmacy, Arab Academy for Science, Technology and Maritime Transport, Abou Keer, Alexandria, Egypt. LA - eng SI - ClinicalTrials.gov/NCT03917940 PT - Journal Article PT - Randomized Controlled Trial DEP - 20231125 PL - England TA - BMC Endocr Disord JT - BMC endocrine disorders JID - 101088676 RN - 0 (Blood Glucose) RN - 0 (Fatty Acids, Omega-3) RN - 0 (Fibronectins) RN - 6KY687524K (glimepiride) RN - 0 (Glycated Hemoglobin) RN - 0 (Insulin) RN - EC 3.5.1.- (Sirtuin 1) SB - IM MH - Humans MH - Blood Glucose/analysis MH - *Diabetes Mellitus, Type 2/drug therapy MH - Double-Blind Method MH - *Fatty Acids, Omega-3 MH - Fibronectins MH - Glycated Hemoglobin MH - Glycemic Control MH - Insulin/metabolism MH - *Insulin Resistance MH - Sirtuin 1 PMC - PMC10675938 OTO - NOTNLM OT - Atherogenic index OT - Glimepiride OT - Irisin OT - Omega-3 OT - Sirtuin-1 OT - T2DM COIS- The authors declare no competing interests. EDAT- 2023/11/25 07:42 MHDA- 2023/11/27 12:42 PMCR- 2023/11/25 CRDT- 2023/11/24 23:49 PHST- 2023/05/25 00:00 [received] PHST- 2023/11/14 00:00 [accepted] PHST- 2023/11/27 12:42 [medline] PHST- 2023/11/25 07:42 [pubmed] PHST- 2023/11/24 23:49 [entrez] PHST- 2023/11/25 00:00 [pmc-release] AID - 10.1186/s12902-023-01511-2 [pii] AID - 1511 [pii] AID - 10.1186/s12902-023-01511-2 [doi] PST - epublish SO - BMC Endocr Disord. 2023 Nov 25;23(1):259. doi: 10.1186/s12902-023-01511-2.