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临床试验/NCT06610812
NCT06610812已完成不适用

KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON Added to Aerobic Exercises POLYCYSTIC OVARIAN ADOLESCENTS

MTI University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
LH/FSH

研究概览

简要总结

study was designed to determine the effect of ketogenic Mediterranean diet versus hypocaloric balanced diet on adolescent female with polycystic ovary disease.

详细描述

this study wsa designed to investigate the effect of the ketogenic Mediterranean diet in comparison with hypo-caloric diet on obese adolescent female's patients with polycystic ovary disease trying to find out a new physical therapy approach that had positive effect in the treatment and care for such cases which could enhance the physical therapy field.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
16 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 1 - All patients were adolescent females. 2- All patients ages ranged from 16 to 21years old. 3- Their BMI ranged from 25kg/m² to 35kg/m². 4- All patients were suffering from hormonal disturbances confirmed by their lab tests and cysts in the ovaries that confirm their diagnosis with polycystic ovary disease.
  • 5- They were conscious and free from any other medical disease.

排除标准

  • Patients were examined by a gynecologist before the study and excluded if they have:
  • Cardiac problems, epileptics and implanted pacemakers.
  • Malignancy and cardiovascular disease.
  • Women with skin infection.
  • Dysesthesia.
  • Cerebrovascular disease.
  • Uncontrolled diabetes.
  • Severe uncontrolled cardiac patient.
  • Liver and kidney dysfunction.

结局指标

主要结局

LH/FSH

时间窗: 3 months

Blood sample was taken from each woman before starting the study to measure the level of androgen in the blood and LH/FSH which will be estimated again after 3months to its level after each type of diet

body mass index

时间窗: 3 months

Weight and height measured while the patient is wearing a thin layer of clothes to calculate the body mass index according to the following equation in both groups: BMI=weight/height2 (Kg/m2)

次要结局

  • waist-hip ratio(3 months)

研究者

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

shaimaa Mohamed hamed

Lecturer of physical therapy for women's health in MTIU

MTI University

研究点 (1)

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