Effect of Laser Acupuncture on Insulin Resistance in Obese Women With Polycystic Ovarian Syndrome
NCT Number: NCT06549647
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Polycystic Ovary Syndrome
Interventions: OTHER: low caloric diet|OTHER: Placebo laser acupoint stimulation|OTHER: Laser Acupuncture
Sponsor: Cairo University
Sex: FEMALE
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2024-12-20

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

Primary Outcome Measures: 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: 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