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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04744896

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Hyperinsulinism	Device: cryolipolysis(3 max cool shaping) Device: Treadmill (jkexer focus 8020A)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

cryolipolysis treadmill cryolipolysis + treadmillcryolipolysis treadmill cryolipolysis + treadmill

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Jan 30, 2022

Anticipated Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cryolipolysis 3max cool shaping device is administered 3 times for each patient, one session every 6 weeks, each session is 40 minutes.	Device: cryolipolysis(3 max cool shaping) cryolioplysis applied over abdomen area
Experimental: treadmill 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.	Device: Treadmill (jkexer focus 8020A) aerobic training ( high intensity interval training)
Active Comparator: treadmill+cryolipolysis aerobic training 3 times per week and cryolipolysis once every 6 weeks	Device: cryolipolysis(3 max cool shaping) cryolioplysis applied over abdomen area Device: Treadmill (jkexer focus 8020A) aerobic training ( high intensity interval training)

Arm

Intervention/Treatment

Experimental: cryolipolysis

3max cool shaping device is administered 3 times for each patient, one session every 6 weeks, each session is 40 minutes.

Device: cryolipolysis(3 max cool shaping)

cryolioplysis applied over abdomen area

Experimental: treadmill

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.

Device: Treadmill (jkexer focus 8020A)

aerobic training ( high intensity interval training)

Active Comparator: treadmill+cryolipolysis

aerobic training 3 times per week and cryolipolysis once every 6 weeks

Device: cryolipolysis(3 max cool shaping)

cryolioplysis applied over abdomen area

Device: Treadmill (jkexer focus 8020A)

aerobic training ( high intensity interval training)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

waist circumference [up to 3 months]
anthropometric measurement measured in centimeter (cm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 28 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo	Giza	Egypt	11865

Sponsors and Collaborators

Cairo University

Investigators

Study Director: amal mo youssef, phd, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Miral Saleh Mohamed, assistant lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT04744896

Other Study ID Numbers:

EHCIBPP

First Posted:

Feb 9, 2021

Last Update Posted:

Feb 23, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Miral Saleh Mohamed, assistant lecturer, Cairo University

pco

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Insulin Resistance

Hyperinsulinism

Study Results

No Results Posted as of Feb 23, 2021