Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Fasting plasma insulin
研究概览
简要总结
This study will be conducted to investigate the effect of laser acupuncture on insulin resistance in obese women with polycystic ovarian syndrome.
详细描述
Women with Polycystic Ovary Syndrome (PCOS) face an increased risk of various health issues, including glucose intolerance, type 2 diabetes, hypertension, dyslipidemia, and subfertility. The prevalence of insulin resistance (IR) in PCOS can range from 44% to 70%, with longitudinal studies indicating that worsening IR over time in obese women with PCOS is associated with an increased risk of early-onset type 2 diabetes.
Conventional interventions, such as oral contraceptives, metformin, and hormonal therapy, have been developed to address the effects of PCOS. However, these treatments can have adverse side effects, including an increased risk of estrogen-related cancers. Consequently, lifestyle modifications to prevent aberrant immune activation and minimize exposure to inflammatory agents have emerged as a more sustainable approach.
Emerging evidence suggests the potential of alternative physical therapy modalities, such as transcutaneous electrical nerve stimulation, electro-acupuncture, and laser acupuncture, in managing PCOS. Laser acupuncture, in particular, has been shown to reduce sympathetic activity, decrease ovarian androgen release, and modulate the activity of higher centers, ultimately influencing gonadotropin-releasing hormone secretion and the menstrual cycle. Additionally, laser acupuncture may reduce the levels of pro-inflammatory cytokines, which contribute to insulin resistance and atherosclerosis.
While a few studies have investigated the effects of laser acupuncture on insulin resistance in obese women with PCOS, further research is needed to provide deeper insights into the benefits of this intervention and its role in managing insulin resistance in this population, which could expand the clinical applications of laser therapy in physical therapy.
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
- Double (Participant, 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
- •Forty obese women with PCOS as clinically diagnosed by gynecologist.
- •Their ages will be ranged from 20 to 35 years old.
- •Their BMI will be ranged from 30-40 kg/m2
- •Their waist/hip ratio will be >0.8
- •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.
- •Skin diseases and any other condition that may prevent the usage of laser (skin cancer, active acne and skin infections).
- •Malignancy
结局指标
主要结局
Fasting plasma insulin
时间窗: 3 months
A venous blood sample will be collected from each participant before and after the end of study. Fasting plasma insulin level will be measured for all participants in both groups (A\&B) after 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 sever insulin resistance is \>12 µIU/ml.
Body mass index (BMI)
时间窗: 3 months
It will be calculated from the weight and height of each participant in both groups (A\&B), before beginning of the study and after end of the study program, according to the following equation: BMI =(Weight (kg))/(Height square (m²)) kg/m²
Waist/hip ratio
时间窗: 3 months
It will be calculated from the waist and hip circumferences for all participants in both groups (A\&B) according to the equation waist/hip ratio= (waist / hip) before and after the end of study.
Oral glucose tolerance test
时间窗: 3 months
A venous blood sample will be collected from each participant before and after the end of study. 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.
Homeostasis Model Assessment (HOMA IR)
时间窗: 3 months
It will be calculated for all participants in both groups (A\&B) 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.
Glucose /insulin ratio
时间窗: 3 months
A venous blood sample will be collected from each participant before and after the end of study. A G/I ratio of less than 4.5 has been shown to be sensitive and specific for insulin resistance in a group of women with PCOS.
次要结局
- Polycystic Ovary Syndrome Quality of Life scale (PCOSQ)(3 months)
研究者
Mena Faiez Shenouda
Principal Investigator
Cairo University