Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients

Study Overview
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Brief Summary
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this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial

Detailed Description
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This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) who were selected from the Outpatient Clinic of Gynecology at Qasr Al Aini University Hospital. Their age ranged from 17-28 years, body mass index was 25-30 Kg/m2. They experienced hyperandrogenism, hyperinsulinemia and amenorrhea not less than 6 months. PCOS females will be randomly assigned into two equal groups: group (A) (control group) consisted of 30 women who received low caloric diet (1200 Cal/day) and group (B) (study group) consisted of 30 women who received the same diet regime and cryolipolysis

Official Title
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Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Device: 3max cool shaping device
* Dietary Supplement: low calolric diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ranges from 20-28 years, body mass index ranges 25-30 Kg/m2. They have pco syndrome . Exclusion Criteria: Diabetic patients. Women with BMI>30 Women having circulatory dysfunction. Women with respiratory or cardiac disease liver disease. Skin disease . Previous abdominal or uterine surgery Physical impairment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: low caloric diet<br>low caloric diet (1200cal/day) | Dietary Supplement: low calolric diet<br>* low caloric diet (1200cal/day)<br>|
| Active Comparator: cryolipolysis<br>cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device | Device: 3max cool shaping device<br>* cryolipolysis sessions are applied on abdomen area each session for 40 min. each<br>Dietary Supplement: low calolric diet<br>* low caloric diet (1200cal/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral adiposity index | indicator of adipose tissue distribution | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | anthropometric measurement by kilogram (kg) | up to 3 months | 
| waist circumference | anthropometric measurement by centimeter (cm) | up to 3 months | 
| high density lipoprotein | blood test | up to 3 months | 
| serum triglyceride level | blood test | up to 3months |