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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: low caloric diet; Other: Placebo laser acupoint stimulation; Other: Laser Acupuncture

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mena Faiez Shenouda, B.Sc; Phone Number: 01227003135; Email: menafaiez18@gmail.com
• Study Contact Backup: Name: Manal Ahmed El-Shafei, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo laser on acpoints + 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.	Other: low caloric diet; 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.; Other: Placebo laser acupoint stimulation; Placebo laser acupoint stimulation will be used for all participants in group (A).
Experimental: Laser acupuncture + 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.	Other: low caloric diet; 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.; Other: Laser Acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)	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	3 months
Waist/hip ratio	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.	3 months
Oral glucose tolerance test	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.	3 months
Fasting plasma insulin	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.	3 months
Glucose /insulin ratio	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.	3 months
Homeostasis Model Assessment (HOMA IR)	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polycystic Ovary Syndrome Quality of Life scale (PCOSQ)	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.	3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Azza Barmoud Nashed Kassab, PhD, Professor of Physical Therapy for Woman's Health, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2024
• Primary Completion (Estimated): November 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome; Insulin Resistance
• Other Study ID Numbers: P.T.REC/012/005182

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No