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

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

NCT ID: NCT06549647

Condition: Polycystic Ovary Syndrome

Conditions: Official terms:
Polycystic Ovary Syndrome
Insulin Resistance
Syndrome

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: low caloric diet
Description: A low caloric diet of 1200 Kcal will be followed by participant for 3 months. The dietary intervention follows a macronutrient ratio of 15% protein, 30% fat, and 55% carbohydrates. Participants are advised to consume 170-240g of complex carbohydrates, 60-100g of fat, and 55-93g of protein per day, with 20-35g of fiber. Patients are also advised to limit salt, tea, and caffeine intake, and receive supplemental vitamins to prevent deficiencies.
Arm group label: Laser acupuncture + low caloric diet
Arm group label: Placebo laser on acpoints + low caloric diet

Intervention type: Other
Intervention name: Placebo laser acupoint stimulation
Description: Placebo laser acupoint stimulation will be used for all participants in group (A).
Arm group label: Placebo laser on acpoints + low caloric diet

Intervention type: Other
Intervention name: Laser Acupuncture
Description: Eazyone EZ1 level laser will be used for the treatment procedures for all participants in group (B) only. Every participant in group (B) will be instructed briefly about the effect of laser acupoints therapy to gain her confidence and co-operation. It will be applied with infrared laser with 830 nm wavelength, 5 W power output and 0.5 J energy on the following acupoints while the patient lie in supine lying position. The head of the machine will be applied perpendicularly on each point for 1 min (17 min total), 3 times/ week for 4 weeks.
Arm group label: Laser acupuncture + low caloric diet

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.

Criteria for eligibility:
Criteria:
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. 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

Gender: Female

Gender based: Yes

Minimum age: 20 Years

Maximum age: 35 Years

Healthy volunteers: No

Start date: August 20, 2024

Completion date: December 20, 2024

Lead sponsor:
Agency: Cairo University
Agency class: Other

Source: Cairo University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06549647