Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome

Not Applicable

Not yet recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: low caloric diet; Other: Placebo laser acupoint stimulation; Other: Laser Acupuncture

• Registration Number: NCT06549647
• Lead Sponsor: Cairo University

Brief Summary

This study will be conducted to investigate the effect of laser acupuncture on insulin resistance in obese women with polycystic ovarian syndrome.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Study Start: 2024-08-20
• Primary Completion: 2024-11-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo laser on acpoints + low caloric diet	Placebo laser acupoint stimulation	It will be consisted of 20 obese women diagnosed as having PCOS. Each will receive placebo laser on acupoints (3 sessions/week, 17 minutes/ session) in addition to low caloric diet for 3 months.
Placebo laser on acpoints + low caloric diet	low caloric diet	It will be consisted of 20 obese women diagnosed as having PCOS. Each will receive placebo laser on acupoints (3 sessions/week, 17 minutes/ session) in addition to low caloric diet for 3 months.
Laser acupuncture + low caloric diet	low caloric diet	It will be consisted of 20 obese women diagnosed as having PCOS who will receive the same low caloric diet as in group (A) in addition to application of laser acupuncture on (REN 4,5), (ST 25,29,36,40), (CV 3,6,10,12),(SP 6), (L14), 1 minutes for each points (17 minutes/session), 3 times/week for 3 months.
Laser acupuncture + low caloric diet	Laser Acupuncture	It will be consisted of 20 obese women diagnosed as having PCOS who will receive the same low caloric diet as in group (A) in addition to application of laser acupuncture on (REN 4,5), (ST 25,29,36,40), (CV 3,6,10,12),(SP 6), (L14), 1 minutes for each points (17 minutes/session), 3 times/week for 3 months.

Primary Outcome Measures

Name	Time	Method
Fasting plasma insulin	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)	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	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	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)	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	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.

Secondary Outcome Measures

Name	Time	Method
Polycystic Ovary Syndrome Quality of Life scale (PCOSQ)	3 months	The quality of life of participants in both groups (A \& B) will be assessed before and after the treatment program using a 26-item questionnaire divided into five sections: emotions (8 items), body hair (5 items), weight concerns (5 items), infertility concerns (4 items), and menstrual irregularities (4 items). Each item is rated on a seven-point scale, where 7 indicates the best situation and 1 the worst. Scores are calculated as means for each domain, with total scores categorized into four intervals reflecting varying effects on quality of life.Ultimately, the first interval values (from 1 to \< 3 points) represent marked effects on quality of life; second interval values (from 3 to \< 4 points) represent the marginal effect on quality of life; third interval values (from 4 to \< 5 points) represent the minimal effect on quality of life; fourth interval (5 points) represents no effect on quality of life.