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

NCT ID: NCT04744896

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-02-28

Brief Summary

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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

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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

Conditions

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Polycystic Ovary Syndrome Hyperinsulinism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cryolipolysis treadmill cryolipolysis + treadmill
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cryolipolysis

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

Group Type EXPERIMENTAL

cryolipolysis(3 max cool shaping)

Intervention Type DEVICE

cryolioplysis applied over abdomen area

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.

Group Type EXPERIMENTAL

Treadmill (jkexer focus 8020A)

Intervention Type DEVICE

aerobic training ( high intensity interval training)

treadmill+cryolipolysis

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

Group Type ACTIVE_COMPARATOR

cryolipolysis(3 max cool shaping)

Intervention Type DEVICE

cryolioplysis applied over abdomen area

Treadmill (jkexer focus 8020A)

Intervention Type DEVICE

aerobic training ( high intensity interval training)

Interventions

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cryolipolysis(3 max cool shaping)

cryolioplysis applied over abdomen area

Intervention Type DEVICE

Treadmill (jkexer focus 8020A)

aerobic training ( high intensity interval training)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

28 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Miral Saleh Mohamed

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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amal mo youssef, phd

Role: STUDY_DIRECTOR

Cairo University

Locations

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Cairo University

Cairo, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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miral saleh, md

Role: CONTACT

01200678845 ext. +010

Facility Contacts

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miral s mohamed, md

Role: primary

01200678845 ext. +012

Other Identifiers

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EHCIBPP

Identifier Type: -

Identifier Source: org_study_id

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