Effect of Metformin and Combination of Olive Oil Plus Nutritional Supplements on Inflammatory Markers IL-6 and IL-8 in PCOS.
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| ClinicalTrials.gov Identifier: NCT05952349 |
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Recruitment Status :
Completed
First Posted : July 19, 2023
Last Update Posted : April 9, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| PCO | Drug: OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD) Drug: Metformin (1000 mg Twice a day) | Phase 2 |
Poly cystic ovary syndrome (PCOS) is an endocrine and metabolic disorder, it affects approximately 4% to 7% of women of child bearing age. PCOS is characterized by poly cystic ovaries, an-ovulation, and other associated features of hyperandrogenism It is pro inflammatory state which is related to insulin resistance, irregular menstruation(oligomenorrhea), type II diabetes, hyperinsulinemia and increased hair growth as signs and symptoms An anti-hyperglycemic agent such as Metformin improves glucose tolerance, and at cellular levels increase the action of insulin without affecting it's secretion. Insulin resistance, hyperinsulinemia and lipid abnormalities are managed by treatment with metformin. Several studies indicate a positive effect of metformin on both metabolic and reproductive aspects in female having PCOS. Metformin is known to reduce obesity and decrease other inflammatory biomarkers like serum c-reactive protein in female having PCOS.
L-carnitine is synthesized by the human body as an endogenous compound, it plays a very important role in the metabolism of fatty acid. L-Carnitine is a cofactor and it help in the oxidation of fatty acids by transporting long-chain of fatty acids across mitochondrial membrane. LC levels are found reduced in patients having PCOS; therefore, for the proper management for insulin resistance and obesity in women adjunctive therapy of LC could be beneficial.
Recent studies on olive oil shows that it helps in reducing fatty liver, while olive oil consumption had no effects on the lipid profile. Olive oil has excellent anti-inflammatory potentials against IL-6,IL-8 and TNF produced into the bloodstream as compared to metformin. As a result, it can be used in PCOS treatment.
IL-6 shows an essential part in endocrine system as a major pro-inflammatory cytokine, particularly related to ovarian growth and the course of fertilization and implantation. IL-6 is involved in low grade chronic inflammation in female with PCOS2. IL-6 also showed to have an effect on insulin resistance and cardiovascular abnormalities . Elevated IL-6 levels is reported to be associated with increase weight, a major risk factor for type II diabetes.
IL-8 is proinflammatory cytokine.Il-8 is chemoattractant and it activate neutrophils. Proinflammatory markers like il-6 and il-8 are involved in the development in development of insulin resistance in PCO. Insulin resistance is involved in exaggeration of inflammatory process.
Arginine is amino acid by nature. It is an essential substrate for nitric oxide synthesis which is involved in insulin signaling. Its supplementation can improve metabolic disorders, immune function, wound healing, lean tissue mass, and brown adipose tissue growth.Co-q10 act as a cofactor in the electron transport chain and in the series of redox reaction which are crucial in the synthesis of adenosine tri phosphate. Co-Q10 is essential of the health of almost all organs and tissues because ATP is the soul requirement of all cellular functions. Coq-10 is the most important lipid antioxidants, it guards against the formation of free radicals and their alterations to proteins, lipids, and DNA.
PCOS is an anti-inflammatory condition. Previous studies shows that level of certain cytokines are elevated in individual with PCOS. Studies related to inflammatory markers and PCOS are very few so, this research will help us in better understanding of inflammatory markers and PCOS and it will also help us in deciding a more better treatment plan for female patients having PCOS.The purpose of this study is to determine the effects of metformin and combination of olive oil plus nutritional supplements after 3 months, on inflammatory markers IL-8 and IL6 in polycystic ovarian syndrome
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 88 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | cross-sectional study |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Metformin and Combination of Olive Oil Plus Nutritional Supplements on Inflammatory Markers IL-6 and IL-8 in PCOS. |
| Actual Study Start Date : | July 1, 2023 |
| Actual Primary Completion Date : | December 31, 2023 |
| Actual Study Completion Date : | April 1, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Combination Therapy Group
ARM# 1 OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)
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Drug: OLIVE OIL 5ML/5MG (BD) NUTRITIONAL SACHET 2100MG (BD)
44 Patients with PCOS receiving olive oil 5ML/5MG (BD) nutritional sachet 2100MG (BD |
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Standard Therapy Group
ARM # 2 METFORMIN 1000MG (BD)
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Drug: Metformin (1000 mg Twice a day)
44 Patients with PCOS receiving Metformin 1000mg (BD) |
- Interleukin 6 level [ Time Frame: 3 months ]measurement of IL-6 level vis ELISA
- Interleukin 8 level [ Time Frame: 3 months ]measurement of IL-8 level vis ELISA
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| Ages Eligible for Study: | 18 Years to 34 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Women diagnosed according to Rotterdam criteria (2 out of 3 should be present)
- Hyperandrogenism
- Polycystic ovaries
- Menstrual irregularities
- Age 18-34 years
Exclusion Criteria:
- 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
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Autoimmune diseases
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952349
| Pakistan | |
| Gynecology and Obstetric, Hayatabad Medical Complex | |
| Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000 | |
| Principal Investigator: | Mohsin Shah, PHD | Department of Physiology, Khyber Medical University, Peshawar Pakistan |
| Responsible Party: | Mohsin Shah, Associate Professor, Khyber Medical University Peshawar |
| ClinicalTrials.gov Identifier: | NCT05952349 |
| Other Study ID Numbers: |
NO:KMU/IBMS/2023/75 |
| First Posted: | July 19, 2023 Key Record Dates |
| Last Update Posted: | April 9, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Metformin L-Carnitine Interleukin-6 L-arginine CoQ-10 |
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Metformin Hypoglycemic Agents Physiological Effects of Drugs |