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临床试验/NCT06015594
NCT06015594已完成不适用

Metformin Treatment in Adolescent Patients With PCOS: A Long-term, Winning Metabolic Choice. Results From a Single Center 5-years Retrospective Clinical Study

University of Cagliari0 个研究点目标入组 168 人开始时间: 2015年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
168
主要终点
Insulin resistance change in eighty hyperinsulinemic patients after metformin therapy and its discontinuation

研究概览

简要总结

This study aimed to understand whether metformin therapy can improve insulin resistance in adolescent PCOS patients, both during treatment and after discontinuation, and to evaluate its action on the hormonal and metabolic pathways.

详细描述

Data were retrospectively retrieved from a database of clinical data collected in the Outpatient Pediatric and Adolescent Gynecology Clinic of the University Hospital "Duilio Casula," Monserrato, Cagliari (Division of Gynecology and Obstetrics, Department of Surgical Sciences, University of Cagliari, Italy), between 2015 and 2019. PCOS diagnosis was adapted for age following the 2019 update from Witchel SF and Carmina's recommendation.

The population consisted of 168 PCOS patients aged 12 to 17. Clinical examination, medical history, blood sampling, and pelvic ultrasound (US) were performed. The number of post-menarche years and the body mass index (BMI) were collected.

The patients were subjected to physical examination to evaluate hirsutism, according to the criteria of the Ferriman and Gallwey score, as well as acne, using the Cremoncini classification.

Each participant received detailed advice on improving their lifestyle, such as physical activity and nutrition. Investigators gave indications of the various food and their weighted intake and a balanced composition of macronutrients (carbohydrates 55%, lipids 25%, protein 20%; fiber ≥25 g/day), as recommended by the Reference intake levels of nutrients and energy for the Italian population (LARN) guidelines. Vegetables, fruit, cereals, fish, and pulses, typical of the Mediterranean style, were included in the diet.

Investigators recommended ≥150 minutes per week of moderate or ≥75 minutes of vigorous-intensity exercise for weight gain prevention, minimizing sedentary time, and including strength training exercises for two days per week, as reported from the 2018 PCOS guideline.

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
10 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pcos Adolescents

排除标准

  • Other type of hyperandrogenism

研究组 & 干预措施

Metformin group

Experimental

Treated with metformin

干预措施: Metformin (Drug)

结局指标

主要结局

Insulin resistance change in eighty hyperinsulinemic patients after metformin therapy and its discontinuation

时间窗: about 3 years

To verify metformin treatment's immediate and long-term efficacy in hyperinsulinemic adolescent patients with PCOS and the evolution of metabolic status after treatment discontinuation.

Androgen levels change in eighty hyperinsulinemic patients after metformin therapy and its discontinuation

时间窗: about 3 years

To compare changes in androgen plasmatic levels such as total testosterone (TT) and delta-4-androstenedione (A) between the hyperinsulinemic adolescent patients with PCOS and the control group who have not received the metformin treatment by immediate and secondary assessment at the end of treatment of androgen plasmatic levels.

次要结局

未报告次要终点

研究者

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

Stefano Di Michele

Principal investigator (Medical doctor)

University of Cagliari

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