Effect of Metformin and Combination of Olive Oil Plus Nutritional Supplements on Inflammatory Markers IL-6 and IL-8 in PCOS.

NCT05952349 | Completed Phase 2 DMC

• 1 other identifier: NO:KMU/IBMS/2023/75
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim is to conduct randomized clinical trial, to determine the effects of metformin and combination of olive oil plus nutritional supplements on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome (PCOS). Women diagnosed with PCOS using "Rotterdam diagnostic criteria" according to which two out of three characters must be their in women of PCOS. The investigators propose that PCOS women have increase levels of IL-6 ,IL-8 and this therapy would have beneficial effects and is able to reduce their increase interleukins levels .

Conditions

PCO

Keywords

Metformin; L-Carnitine; Interleukin-6; L-arginine; CoQ-10

Outcome Measures

Primary Outcomes (2)

• Interleukin 6 level

  measurement of IL-6 level vis ELISA

  3 months

• Interleukin 8 level

  measurement of IL-8 level vis ELISA

  3 months

Study Arms (2)

Combination Therapy Group

ACTIVE COMPARATOR

ARM# 1 OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)

Drug: OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)

Standard Therapy Group

OTHER

ARM # 2 METFORMIN 1000MG (BD)

Drug: Metformin (1000 mg Twice a day)

Interventions

OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD) DRUG

44 Patients with PCOS receiving olive oil 5ML/5MG (BD) nutritional sachet 2100MG (BD

Combination Therapy Group

Metformin (1000 mg Twice a day) DRUG

44 Patients with PCOS receiving Metformin 1000mg (BD)

Standard Therapy Group

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women diagnosed according to Rotterdam criteria (2 out of 3 should be present)
• Hyperandrogenism
• Polycystic ovaries
• Menstrual irregularities
• Age 18-34 years

You may not qualify if:

• Previous history of Cushing's syndrome
• Women using other medications simultaneously which may affect hormonal changes
• Previous history of ovarian surgery
• Congenital adrenal hyperplasia
• Thyroid diseases
• Autoimmune diseases

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Gynecology and Obstetric, Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (11)

• Ortega-Gonzalez C, Luna S, Hernandez L, Crespo G, Aguayo P, Arteaga-Troncoso G, Parra A. Responses of serum androgen and insulin resistance to metformin and pioglitazone in obese, insulin-resistant women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Mar;90(3):1360-5. doi: 10.1210/jc.2004-1965. Epub 2004 Dec 14.

  PMID: 15598674 BACKGROUND

• Xu X, Du C, Zheng Q, Peng L, Sun Y. Effect of metformin on serum interleukin-6 levels in polycystic ovary syndrome: a systematic review. BMC Womens Health. 2014 Aug 5;14:93. doi: 10.1186/1472-6874-14-93.

  PMID: 25096410 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.

  PMID: 8177055 BACKGROUND

• Hwang KR, Choi YM, Kim JJ, Chae SJ, Park KE, Jeon HW, Ku SY, Kim SH, Kim JG, Moon SY. Effects of insulin-sensitizing agents and insulin resistance in women with polycystic ovary syndrome. Clin Exp Reprod Med. 2013 Jun;40(2):100-5. doi: 10.5653/cerm.2013.40.2.100. Epub 2013 Jun 30.

  PMID: 23875167 BACKGROUND

• Takemura Y, Osuga Y, Yoshino O, Hasegawa A, Hirata T, Hirota Y, Nose E, Morimoto C, Harada M, Koga K, Tajima T, Yano T, Taketani Y. Metformin suppresses interleukin (IL)-1beta-induced IL-8 production, aromatase activation, and proliferation of endometriotic stromal cells. J Clin Endocrinol Metab. 2007 Aug;92(8):3213-8. doi: 10.1210/jc.2006-2486. Epub 2007 May 15.

  PMID: 17504902 BACKGROUND

• Sangeeta S. Metformin and pioglitazone in polycystic ovarian syndrome: a comparative study. J Obstet Gynaecol India. 2012 Oct;62(5):551-6. doi: 10.1007/s13224-012-0183-3. Epub 2012 Oct 16.

  PMID: 24082557 BACKGROUND

• Yahay M, Heidari Z, Allameh Z, Amani R. The effects of canola and olive oils consumption compared to sunflower oil, on lipid profile and hepatic steatosis in women with polycystic ovarian syndrome: a randomized controlled trial. Lipids Health Dis. 2021 Jan 29;20(1):7. doi: 10.1186/s12944-021-01433-9.

  PMID: 33514384 BACKGROUND

• Peng Z, Sun Y, Lv X, Zhang H, Liu C, Dai S. Interleukin-6 Levels in Women with Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis. PLoS One. 2016 Feb 5;11(2):e0148531. doi: 10.1371/journal.pone.0148531. eCollection 2016.

  PMID: 26849353 BACKGROUND

• Abraham Gnanadass S, Divakar Prabhu Y, Valsala Gopalakrishnan A. Association of metabolic and inflammatory markers with polycystic ovarian syndrome (PCOS): an update. Arch Gynecol Obstet. 2021 Mar;303(3):631-643. doi: 10.1007/s00404-020-05951-2. Epub 2021 Jan 13.

  PMID: 33439300 BACKGROUND

• Wu G, Meininger CJ, McNeal CJ, Bazer FW, Rhoads JM. Role of L-Arginine in Nitric Oxide Synthesis and Health in Humans. Adv Exp Med Biol. 2021;1332:167-187. doi: 10.1007/978-3-030-74180-8_10.

  PMID: 34251644 BACKGROUND

• Saini R. Coenzyme Q10: The essential nutrient. J Pharm Bioallied Sci. 2011 Jul;3(3):466-7. doi: 10.4103/0975-7406.84471. No abstract available.

  PMID: 21966175 BACKGROUND

MeSH Terms

Interventions

Olive Oil; Metformin

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Mohsin Shah, PHD

  Department of Physiology, Khyber Medical University, Peshawar Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: cross-sectional study

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 19, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: April 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)