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临床试验/NCT05348967
NCT05348967撤回不适用

Association of D-chiro-inositol and the Ketogenic Diet in the Treatment of Overweight/Obese Patients With Insulin Resistance and Polycystic Ovary Syndrome

Lo.Li.Pharma s.r.l1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年10月14日最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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