Association of D-chiro-inositol and the Ketogenic Diet in the Treatment of Overweight/Obese Patients With Insulin Resistance and Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- HOMA index
研究概览
简要总结
The study aims to evaluate whether the combination of a product based on D-chiro-inositol and the ketogenic diet can improve the metabolic/endocrine picture of overweight/obese women with PCOS, with insulin resistance, in a shorter time than the ketogenic diet alone
详细描述
Weight loss is the main approach to counteract PCOS phenotype, improving ovulatory function and reducing insulin and systemic levels of free testosterone.
It is not yet ascertained whether the composition of the diet can have a positive effect on the metabolic pattern; however, it should be considered that blood glucose levels are influenced by the intake of carbohydrates that regulate insulin secretion.
Therefore, low-carbohydrate diets should be preferred over standard low-calorie diets, in terms of improvement in metabolic/endocrine parameters, which accompanies weight loss in women with PCOS.
The ketogenic diet (KD), a very low-carbohydrate diet capable of developing physiological ketosis, has proven very effective aganist various pathological conditions, including obesity and type 2 diabetes.
In particular, in the context of KD there is an ever increasing interest in VLCKD (Very Low Calorie Ketogenic Diet) diets with very low calorie content as well as carbohydrates, which have been shown to be effective and safe in the management of metabolic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with age between 25 and 40 years
- •Diagnosis of Polycystic Ovary Syndrome (PCOS)
- •Diagnosis of insulin-resistance (HOMA ≥2.5)
- •26 ≤ BMI ≤32
排除标准
- •Subjects with no indication for treatment
- •Pregnancy, breastfeeding
- •Treatment with drugs or supplements that interfere with the mechanism of action of insulin
结局指标
主要结局
HOMA index
时间窗: Three time points: change in HOMA index from the baseline to 2 and 4 months
Reduction of HOMA index
次要结局
未报告次要终点
