Effect of High Intensity Interval Training on Insulin Resistance in Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome.
详细描述
Women with polycystic ovarian syndrome (PCOS) are at increased risk for glucose intolerance, dyslipidemia, subfertility, obstetric complications and psychosexual disorders.
The prevalence of insulin resistance in PCOS can range from 44% to 70%. Studies have indicated that worsening of insulin resistance over time in obese women with PCOS is associated with early development of diabetes mellitus type 2.
Interventions like oral contraceptive pills give the higher risk of endometrial cancer for women with PCOS. However, lifestyle correction appears to be the sustainable therapy of PCOS.
High-intensity interval training (HIIT) consists of short periods of intense exercise (80% of maximal heart rate) alternated with periods of active recovery or rest. It is a relatively time-efficient training strategy to improve metabolic health and has been considered more enjoyable than moderate-to-vigorous intensity continuous training HIIT increases skeletal muscle oxidative capacity and appears to be effective in improving insulin sensitivity, particularly in those at increased risk type 2 diabetes mellitus.
Intermittent fasting had a powerful effect on improvement of glucose metabolism by lowering insulin resistance, improvement of systemic inflammatory diseases and even expansion of life span.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obese women with polycystic Ovarian Syndrome (PCOS) as clinically diagnosed by the gynecologist.
- •Their ages will be ranged from 20 to 35 years old.
- •Their body mass index will be ranged from 30-40 kg/m
- •Their waist/hip ratio will be > 0.
- •All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.
排除标准
- •Cushing syndrome, diabetes mellitus.
- •Thyroid dysfunction.
- •Hypothalamic amenorrhea, ovarian hyperplasia.
- •Respiratory, renal and liver dysfunction.
结局指标
主要结局
Body weight
时间窗: 12 weeks
Body weight will be measured by using weight and height scale before and after treatment program.
Body mass index
时间窗: 12 weeks
It will be calculated by dividing weight in kilograms divided by height meter square.
Waist circumference
时间窗: 12 weeks
The waist circumference will be measured by tape measure from the narrowest point between the lower border of the ribcage and the iliac crest at the end of normal expiration.
Hip circumference
时间窗: 12 weeks
Hip circumference will be measured at the widest part of the hip using the tape measurement.
Waist/ hip ratio
时间窗: 12 weeks
Waist /hip ratio will be calculated by dividing waist circumference by hip circumference.
Oral glucose tolerance test
时间窗: 12 weeks
Venous blood sample will be collected from each participant to determine level of oral glucose tolerance test. The 2-hour plasma glucose level \<140 mg/dL (7.8 MMOL/L) is considered normal. A blood glucose level between 140 and 199 mg/dL (7.8 and 11 MMOL/L) is considered impaired glucose tolerance, or pre- diabetes.
Fasting plasma insulin
时间窗: 12 weeks
Venous blood sample will be collected from each participant to determine level of fasting plasma insulin level at least 8 hours of fasting. Normal insulin level is 3-8µIU/ml, mild insulin resistance is 8-10µIU/ml, moderate insulin resistance is 10-12µIU/ml and severe insulin resistance is \>12 µIU/ml.
Glucose /insulin ratio
时间窗: 12 weeks
A glucose /insulin ratio of less than 4.5 has been shown to be sensitive and specific for insulin resistance in a group of women with polycystic Ovarian Syndrome.
Homeostasis Model Assessment (HOMA IR)
时间窗: 12 weeks
Venous blood sample will be collected from each participant to determine level of homeostasis Model Assessment (HOMA IR). It will be calculated for all participants before and after the end of the treatment according to the following equation: HOMA.IR = insulin (MU/L) × glucose (mmol/L)/22.5. HOMA\_IR ≥2.5 should be considered a reasonable indicator of insulin resistance.
次要结局
- Assessment of quality of life(12 weeks)
研究者
Hager Tharwat Mohamed
Principal investigator
Cairo University