Independent and Additive Effects Of Micronutrients With Metformin In Patients With PCOS

Summary

The investigators aim to conduct a double blind randomized clinical trial to study the independent and additive effects of micronutrients (Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 ) with Metformin in patients with PCOS .Women diagnosed with PCOS according to National Institute of Health( NIH) 2012 extension of European Society of Human Reproduction and Embryology /American Society of Reproductive Medicine ESHRE /ASRM 2003 criteria will be included according to a specific phenotype including Hyperandrogenism, Ovulatory dysfunction and Polycystic Ovarian Morphology. The investigators propose that by using combination therapy with micro supplements like Resveratrol, Acetyl-L Carnitine, L Arginine and COQ10 will produce greater improvement better than or at least comparable to Metformin in metabolic and endocrine profile of patients with PCOS.

Timeline

Start

2022-12-07

Primary completion

2023-12-30

Completion

2024-02-07

Publications

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• Background Rege SD, Kumar S, Wilson DN, Tamura L, Geetha T, Mathews ST, Huggins KW, Broderick TL, Babu JR. Resveratrol protects the brain of obese mice from oxidative damage. Oxid Med Cell Longev. 2013;2013:419092. doi: 10.1155/2013/419092. Epub 2013 Sep 15.
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• Background Amin MM, Asaad GF, Abdel Salam RM, El-Abhar HS, Arbid MS. Novel CoQ10 antidiabetic mechanisms underlie its positive effect: modulation of insulin and adiponectine receptors, Tyrosine kinase, PI3K, glucose transporters, sRAGE and visfatin in insulin resistant/diabetic rats. PLoS One. 2014 Feb 20;9(2):e89169. doi: 10.1371/journal.pone.0089169. eCollection 2014.
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• Background Malapaka RRV, Khoo S, Zhang J, Choi JH, Zhou XE, Xu Y, Gong Y, Li J, Yong EL, Chalmers MJ, Chang L, Resau JH, Griffin PR, Chen YE, Xu HE. Identification and mechanism of 10-carbon fatty acid as modulating ligand of peroxisome proliferator-activated receptors. J Biol Chem. 2012 Jan 2;287(1):183-195. doi: 10.1074/jbc.M111.294785. Epub 2011 Oct 28.
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• Background Piatti PM, Monti LD, Valsecchi G, Magni F, Setola E, Marchesi F, Galli-Kienle M, Pozza G, Alberti KG. Long-term oral L-arginine administration improves peripheral and hepatic insulin sensitivity in type 2 diabetic patients. Diabetes Care. 2001 May;24(5):875-80. doi: 10.2337/diacare.24.5.875.
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• Background Velazquez EM, Mendoza S, Hamer T, Sosa F, Glueck CJ. Metformin therapy in polycystic ovary syndrome reduces hyperinsulinemia, insulin resistance, hyperandrogenemia, and systolic blood pressure, while facilitating normal menses and pregnancy. Metabolism. 1994 May;43(5):647-54. doi: 10.1016/0026-0495(94)90209-7.
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• Background Morley LC, Tang T, Yasmin E, Norman RJ, Balen AH. Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. Cochrane Database Syst Rev. 2017 Nov 29;11(11):CD003053. doi: 10.1002/14651858.CD003053.pub6.
• Zahra M, Shah M, Iqbal F, Zubair T, Habib R, Zulfiqar F. Efficacy Of Combined Nutritional And Pharmacological Interventions In PCOS: A Six Month Randomized Controlled Trial. Naunyn Schmiedebergs Arch Pharmacol. 2026 Feb;399(3):3461-3476. doi: 10.1007/s00210-025-04626-6. Epub 2025 Sep 30.

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Indications