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

NCT06549647 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005182
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Polycystic Ovary Syndrome Quality of Life scale (PCOSQ)

  3 months

Study Arms (2)

Placebo laser on acpoints + low caloric diet

PLACEBO COMPARATOR

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; Other: Placebo laser acupoint stimulation

Laser acupuncture + low caloric diet

EXPERIMENTAL

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; Other: Laser Acupuncture

Interventions

low caloric diet OTHER

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.

Laser acupuncture + low caloric diet; Placebo laser on acpoints + low caloric diet

Placebo laser acupoint stimulation OTHER

Placebo laser acupoint stimulation will be used for all participants in group (A).

Placebo laser on acpoints + low caloric diet

Laser Acupuncture OTHER

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.

Laser acupuncture + low caloric diet

Eligibility Criteria

• Age: 20 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Azza Barmoud Nashed Kassab, PhD

  Professor of Physical Therapy for Woman's Health, Cairo University

  STUDY CHAIR

Central Study Contacts

Mena Faiez Shenouda, B.Sc

CONTACT

01227003135; menafaiez18@gmail.com

Manal Ahmed El-Shafei, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: August 20, 2024
• Primary Completion: November 20, 2024
• Study Completion: December 20, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08