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Spots Global Cancer Trial Database for Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome

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Trial Identification

Brief Title: Vitamin D Status in Relation to Insulin Sensitivity Among Saudi Women With Polycystic Ovary Syndrome

Official Title: Vitamin D Status in Relation to Insulin Sensitivity, Resistance and Inflammatory Response Among Saudi Women With Polycystic Ovary Syndrome

Study ID: NCT02164552

Study Description

Brief Summary: The study tests the hypothesis that correction of vitamin D deficiency among women with PCOS will improve insulin sensitivity and resistance and inflammatory response to PCOS.

Detailed Description: Polycystic ovary syndrome (PCOS) is a common complex and heterogenous endocrine disorder. It affects ≤10% of women of reproductive age, with approximately 16%-80% of the affected women being obese. Polycystic ovary syndrome frequently is associated with insulin resistance (IR) accompanied by compensatory hyperinsulinemia, and IR is aggravated by the interaction between obesity and the syndrome. Moreover, the contribution of body mass and/or body fat distribution to IR of PCOS remains controversial. In addition, women with PCOS with IR are at an increased risk of developing diabetes, hypertension, dyslipidemia and atherosclerosis. Preliminary data on the local women with PCOS showed high prevalence of vitamin D deficiency (serum 25(OH)D \< 50 nmol/L). Recent studies showed that vitamin D deficiency is linked to IR, type 2 diabetes mellitus, obesity, inflammation and cardio vascular disease. Several studies have demonstrated that serum 25(OH)D levels were negatively correlated with body mass index (BMI), body fat, and IR. These conditions are common among women with PCOS. Accordingly, it is anticipated that vitamin D deficiency and/or insufficiency may contribute to the endocrine and metabolic disarrangements among women with PCOS. Such adverse effects may further contribute to the risk of further long term complications among women with PCOS.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Center of Excellence for Osteoporosis Research, King Abdulaziz University, Jeddah, Makkah, Saudi Arabia

Contact Details

Name: Abdulrahim A Rouzi, FRCPC

Affiliation: Center of Excellence for Osteoporosis Research and Faculty of Medicine, King Abdulaziz University

Role: PRINCIPAL_INVESTIGATOR

Name: Mohammed-Salleh M Ardawi, PhD, FRCPath

Affiliation: Center of Excellence for Osteoporosis Research, and Faculty of Medicine, King Abdulaziz University

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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