Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients

Not Applicable

• Conditions: Hyperinsulinism; Polycystic Ovary Syndrome
• Interventions: Device: cryolipolysis(3 max cool shaping); Device: Treadmill (jkexer focus 8020A)

• Registration Number: NCT04744896
• Lead Sponsor: Cairo University

Brief Summary

this study will be carried to investigate the effect of cryolipolysis and high intensity interval training on insulin resistance and body composition in pco women

Detailed Description

This study will be carried out on ninety females with polycystic ovarian syndrome (PCOS)l. Their age ranges from 17-28 years, body mass index 25-30 Kg/m2. They experience hyperandrogenism and hyperinsulinemia.

PCOS females will be randomly assigned into three equal groups: group (A) consists of 30 women who receive cryolipolysis and group (B) consists of 30 women who receive high intensity interval training and group (C) receive both

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Last Update Submitted: 2021-02-21
• Last Update Posted: 2021-02-23
• Study Start: 2021-03-01
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• women diagnosed with polycystic ovarian syndrome
• age ranges from 17-28 years
• body mass index ranges 25-30 Kg/m2

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
• any medications affecting hormones
• any physical impairments
• Physical impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treadmill+cryolipolysis	Treadmill (jkexer focus 8020A)	aerobic training 3 times per week and cryolipolysis once every 6 weeks
cryolipolysis	cryolipolysis(3 max cool shaping)	3max cool shaping device is administered 3 times for each patient, one session every 6 weeks, each session is 40 minutes.
treadmill	Treadmill (jkexer focus 8020A)	aerobic training in form of high intensity interval training, three times per week for 3 weeks by treadmill(jkexer focus 8020A) each session is for 20 minutes.
treadmill+cryolipolysis	cryolipolysis(3 max cool shaping)	aerobic training 3 times per week and cryolipolysis once every 6 weeks

Primary Outcome Measures

Name	Time	Method
fat percentage	up to 3 months	overall body fat percentage measured by body fat analyzer in percentage (%)
HOMA IR	3 months	blood test
weight	up to 3 months	anthropometric measure measured in kilogram (kg)

Secondary Outcome Measures

Name	Time	Method
waist circumference	up to 3 months	anthropometric measurement measured in centimeter (cm)

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Giza, Egypt