COMPARATIVE ASSESSMENT OF TRIGONELLA FOENUM-GRAECUM & CINNAMON VERSUS SITAGLIPTIN ON GLYCEMIC CONTROL AND BODY WEIGHT IN TYPE 2 DIABETES: A RANDOMIZED CLINICAL TRIAL

Main Article Content

Syeda Amber Zaidi
Syed Mohsin Turab
Muhammad Arif
M. Sajid Abbas Jafri
Khalid Mustafa

Keywords

Sitagliptin, Cinnamon, Trigonella foenum-graecum (Fenugreek), Metabolic syndrome, Type 2 diabetes

Abstract

Background. Metabolic syndrome and type 2 diabetes are growing health concerns worldwide, associated with increased risks of cardiovascular disease, kidney failure, and other complications. Conventional treatments like sitagliptin, a DPP-4 inhibitor, have shown efficacy in managing type 2 diabetes by improving glycemic control. However, there is a growing interest in exploring complementary and alternative therapies, including herbal remedies like Trigonella foenum-graecum (Fenugreek) and cinnamon, which have been traditionally used to manage blood sugar levels.Objectives: The purpose of the study is to assess the efficacy of sitagliptin and herbal drugs such as Trigonella foenum-graecum (Fenugreek) and cinnamon in treating patients with metabolic syndrome and type 2 diabetes. Methodology This prospective comparative study was conducted in the department of Medicine at Hamdard University Hospital (Taj Medical Complex) Karachi over a period of six months from July 23 to December 2023. Two hundred participants were selected and they were divided into two groups of one hundred participants each by a process of random sampling. Group A was given sitagliptin and the second group was given herbal medicine for 12 weeks. The efficacy of the two treatments was evaluated by measuring the Fasting Blood Glucose (FBS), Random Blood Glucose (RBS), Glycosylated Hemoglobin (HbA1c), Body Mass Index (BMI), and Waist-Hip Ratio on days 0, 30, 60 and 90 of treatment.. Results: The study demonstrated a statistically significant reduction in fasting blood sugar (FBS), random blood sugar (RBS), and glycated hemoglobin (HbA1c) levels in both the herbal and allopathic treatment groups. Notably, the herbal group, which received Trigonella foenum-graecum (Fenugreek) and cinnamon, showed superior efficacy by day 90 compared to the allopathic group. This suggests that the combination of Fenugreek and cinnamon could serve as a potential alternative or complement to conventional treatments for managing glycemic levels in patients with type 2 diabetes and metabolic syndrome.Conclusions: Based on the study's findings, it can be concluded that both sitagliptin and the herbal compound containing Trigonella foenum-graecum (Fenugreek) seed and cinnamon bark powder demonstrated potential benefits in managing patients with metabolic syndrome and type 2 diabetes. The herbal remedy showed promise in improving glycemic control and anthropometric parameters, although the magnitude of effects may vary compared to sitagliptin.


 

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References

1. Zhong Y, Hu M, Wang Q, Yang Z, Zhu N, Wang F, Zhang Z, Zhang C, Min J, Wang H, Chen F, Zhao X and Zhang X (2021). The prevalence and related factors of metabolic syndrome in outpatients with first-episode drug-naive major depression comorbid with anxiety. Scientific Reports., 11:3324. https://doi.org/10.1038/s41598-021-81653-2
2. American Diabetes Association (2024). Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024 Diabetes Care. ;47(Suppl. 1):S20–S42
3. Chowdhury MZ, Anik AM, Farhana Z, Bristi PD, Al Mamun BMA, Uddin MJ, Fatema J, Akter T, Tani TA, Rahman M and Turin TC (2018). Prevalence of metabolic syndrome in Bangladesh: a systematic review and meta-analysis of the studies. Public Health, 18:308 https://doi.org/10.1186/s12889-018-5209-z.
4. Adil SO, Islam MA, Musa KI, and Shafique K (2023). Prevalence of Metabolic Syndrome among Apparently Healthy Adult Population in Pakistan: A Systematic Review and Meta- Analysis. Healthcare, 11, 531. https://doi.org/10.3390/healthcare11040531.
5. Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K, Duncan BB, Stein C, Basit A, Chan JCN, Mbanya JC, Pavkov ME, Ramachandaran A, Wild SH, James S, Herman WH, Zhang P, Bommer C, Kuo S, Boyko EJ, Magliano DJ (2022). IDF diabetes atlas: global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract, Jan:183:109119. doi: 10.1016/j.diabres.2021.109119.
6. Hematyar J, Rashidi H, Zakerkish M, Payami SP and Ghaderian SB (2022). Effect of Sitagliptin Versus Glibenclamide on Glycemic Markers, Lipid Profile Inflammatory and Oxidative Stress Factors in Type 2 Diabetes Patients: a Double-Blinded Randomized
Controlled Trial. MAEDICA – a Journal of Clinical Medicine, 17(4): 762-770. https://doi.org/10.26574/maedica.2022.17.4.762
7. Cortez-Navarrete M, Pérez-Rubio KG and Escobedo-Gutiérrez MDJ (2023). Role of Fenugreek, Cinnamon, Curcuma longa, Berberine and Momordica charantia in Type 2 Diabetes Mellitus Treatment: A Review. Pharmaceuticals, 16, 515. https://doi.org/ 10.3390/ph16040515.
8. Ota A and Ulrih NP (2017). An Overview of Herbal Products and Secondary Metabolites Used for Management of Type Two Diabetes. Front. Pharmacol. 8:436. doi: 10.3389/fphar.2017.00436
9. Vajdi M, Noshadi N, Bonyadian A, Golpour-Hamedani S, Alipour B, Tabrizi FPF, Abbasalizad-Farhangi M and Askari G (2024). Therapeutic effect of fenugreek supplementation on type 2 diabetes mellitus: A systematic review and meta-analysis of clinical trials. Heliyon 10. https://doi.org/10.1016/j.heliyon.2024.e36649
10. Medagama AB (2015). The glycaemic outcomes of Cinnamon, a review of the experimental evidence and clinical trials. Nutr. J. 14, 108. doi: 10.1186/s12937 015-0098- 9
11. Zarezadeh M, Musazadeh V, Foroumandi E, Keramati M, Ostadrahimi A and Mekary RA (2023). The effect of cinnamon supplementation on glycemic control in patients with type 2 diabetes or with polycystic ovary syndrome: an umbrella meta-analysis on interventional meta-analyses. Diabetology & Metabolic Syndrome, 15:127
12.Kelsey et al. Methods in Observational Epidemiology, 2nd edition. OpenEpi, version 3. open Source Calculator-SSCohort. https://www.openepi.com/Sample Size/SScohort.htm.
13.Gong Y, Bai X, Zhang D, Yang X, Qin Z, Yang Y, Zhou Y, Meng J and Liu X (2024). Effect of DPP-4i inhibitors on renal function in patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. Lipids in Health and Disease, 23:157 https://doi.org/10.1186/s12944-024-02132-x.
14. Wang X, Zhao B, Sun H, You H and Qu S (2022). Effects of sitagliptin on intrahepatic lipid content in patients with non-alcoholic fatty liver disease. Front. Endocrinol., 13:866189. doi: 10.3389/fendo.2022.866189.
15. Fuchigami A, Shigiyama F, Kitazawa T, Okada Y, Ichijo T, Higa M, Hiyoshi T, Inoue I, Iso K, Yoshii H, Hirose T and Kumashiro N (2020). Efcacy of dapaglifozinversus sitagliptin on cardiometabolic risk factors in Japanese patients with type 2 diabetes: a prospective, randomized study (DIVERSITY-CVR). Cardiovascular diabetology, 19:1, https://doi.org/10.1186/s12933-019-0977-z
16. Seino Y, Kaku K, Kadowaki T, Okamoto T, Sato A, Shirakawa M, O'Neill EA, Engel SS and Kaufman KD (2021). A randomized, placebo-controlled trial to assess the efficacy and safety of sitagliptin in Japanese patients with type 2 diabetes and inadequate glycaemic control on ipragliflozin. Diabetes Obes Metab, Jun;23(6):1342-1350. doi: 10.1111/dom.14346.
17. Hussain M, Rafique MA, Iqbal J and Akhtar L (2019). Effect of sitagliptin and glimepiride on C-reactive protein (CRP) in overweight Type-2 diabetic patients. Pak J Med Sci., 35(2):383-387. doi: https://doi.org/10.12669/pjms.35.2.645.
18. Yu T, Lu K, Cao X, Xia H, Wang S, Sun G, Chen L and Liao W (2023). The Effect of Cinnamon on Glycolipid Metabolism: A Dose–Response Meta-Analysis of Randomized Controlled Trials. Nutrients, 15, 2983. https://doi.org/10.3390/ nu15132983. (Tingqing Yu et al., 2023)
19. Sweta Vyas (2023). Effect of fenugreek (Methi dana) on carbohydrate and protein metabolism in diabetic patients. International Journal of Home Science; 9(1): 261-263.
20. Zare R, Nadjarzadeh A, Zarshenas MM, Shams M and Heydari M (2019). Efficacy of cinnamon in patients with type II diabetes mellitus: A randomized controlled clinical trial. Clin. Nutr., 38, 549–556.
21. Zelicha H, Yang J, Henning SM, Huang J, Lee RP, Thames M, Livingston EH, Heber D and Li Z (2024). Effect of cinnamon spice on continuously monitored glycemic response in adults with prediabetes: a 4-week randomized controlled crossover trial. The American Journal of Clinical Nutrition, 119: 649–657. https://doi.org/10.1016/j.ajcnut.2024.01.008
22. Deyno S, Eneyew K, Seyfe S, Tuyiringire N, Peter E, Muluye RA, Tolo CU and Ogwang PE (2019). Efficacy and safety of cinnamon in type 2 diabetes mellitus and pre-diabetes patients: A meta-analysis and meta-regression. Diabetes Res Clin Pract., Oct:156:107815. doi: 10.1016/j.diabres.2019.107815.
23. Kizilaslan N and Erdem NZ (2019). The Effect of Different Amounts of Cinnamon Consumption on Blood Glucose in Healthy Adult Individuals. International Journal of Food Science Volume 2019, Article ID 4138534, 9 pages https://doi.org/10.1155/2019/4138534
24. Baset ME, Ali TI, Elshamy H, El Sadek AM, Sami DG, Badawy MT, Abou-Zekry SS, Heiba HH, Saadeldin MK and Adellatif A (2020). Anti-diabetic effects of Fenugreek (Trigonella foenum-graecum), A comparison between oral and intraperitoneal administration- an animal study, International Journal of Functional Nutrition, 1, 2. DOI: 10.3892/ijfn.2020.2
25. Verma N, Usman K, Patel N, Jain A, Dhakre S, Swaroop A, Bagchi M, Kumar P, Preuss HG and Bagchi D (2016). A multicenter clinical study to determine the efficacy of a novel fenugreek seed (Trigonella foenum-graecum) extract (Fenufuro TM) in patients with type 2 diabetes. Food Nutr Res., Oct 11:60:32382. doi: 10.3402/fnr.v60.32382. (Verma et al., 2016)
26. Ranade M and Mudgalkar N (2017). A simple dietary addition of fenugreek seed leads to the reduction in blood glucose levels, A parallel group, randomized single-blind trial. Ayurveda, 38(1-2): 24-27. DOI: 10.4103/ayu.AYU_209_15
27. Zarvandi M, Rakhshandeh H, Abazari M, Shfiee-Nick R and Ghorbani A (2017). Safety and efficacy of a polyherbal formulation for the management of dyslipidemia and hyperglycemia in patients with advanced-stage of type 2 diabetes. Biomedicine and Pharmacotherapy, Volume 89: 69-75. https://doi.org/10.1016/j.biopha.2017.02.016
28. Hassani SS, Arezodar FF, Esmaeili SS and Gholami-Fesharaki M (2019). Effect of Fenugreek Use on Fasting Blood Glucose, Glycosylated Hemoglobin, Body Mass Index, Waist Circumference, Blood Pressure and Quality of Life in Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trials. GMJ., 8:e1432.
29. Janani L, Bamehr H, Tanha K, Mirzabeigi P, Montazeri H and Tarighi P (2021). Effects of Sitagliptin as Monotherapy and Add-On to Metformin on Weight Loss among Overweight and Obese Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis. Drug Res., 71: 477–488 DOI 10.1055/a-1555-2797
30. Kaku K, Kadowaki T, Seino Y, Okamoto T, Shirakawa M, Sato A, O'Neill EA, Engel SS and Kaufman KD (2021). Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes and inadequate glycaemic control on Sitagliptin. Diabetes ObesMetab. 2021;23:2099–2108. DOI: 10.1111/dom.14448.