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

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: low calolric diet; Device: 3max cool shaping device

• Registration Number: NCT04745338
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-04
• Last Update Submitted: 2021-02-04
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09
• Study Start: 2021-03-01
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low caloric diet	low calolric diet	low caloric diet (1200cal/day)
cryolipolysis	3max cool shaping device	cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device
cryolipolysis	low calolric diet	cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device

Primary Outcome Measures

Name	Time	Method
Visceral adiposity index	3 months	indicator of adipose tissue distribution

Secondary Outcome Measures

Name	Time	Method
waist circumference	up to 3 months	anthropometric measurement by centimeter (cm)
serum triglyceride level	up to 3months	blood test
weight	up to 3 months	anthropometric measurement by kilogram (kg)
high density lipoprotein	up to 3 months	blood test

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt