Clinical trial NCT06549647: Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome
Official title: Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: 3 months
measure: Waist/hip ratio
timeFrame: 3 months
measure: Oral glucose tolerance test
timeFrame: 3 months
measure: Fasting plasma insulin
timeFrame: 3 months
measure: Glucose /insulin ratio
timeFrame: 3 months
measure: Homeostasis Model Assessment (HOMA IR)
timeFrame: 3 months
Secondary outcomes:
measure: Polycystic Ovary Syndrome Quality of Life scale (PCOSQ)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Physical Therapy for Woman's Health, Cairo University
name: Azza Barmoud Nashed Kassab, PhD
role: STUDY_CHAIR
References: