跳至主要内容
临床试验/NCT02164552
NCT02164552Unknown不适用

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

King Abdulaziz University1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
340
试验地点
1
主要终点
Correction of vitamin D deficiency improves insulin resistance compared to placebo

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • PCOS diagnosis to include three of the Rotterdam criteria

排除标准

  • pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for >/3 months before the study smokers

结局指标

主要结局

Correction of vitamin D deficiency improves insulin resistance compared to placebo

时间窗: 24 weeks

The primary endpoint was an improvement in insulin resistance parameters \[Fasting serum insulin,glucose-to-insulin ratio (GIR) and homeostasis model assessment (HOMA) \] from baseline and at 24 weeks in vitamin D supplemented as compared with placebo groups.

次要结局

  • Insulin sensitivity(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed-Salleh M. Ardawi

Professor

King Abdulaziz University

研究点 (1)

Loading locations...

相似试验