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

NCT ID: NCT04745338

Last Updated: 2021-02-09

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

60 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 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

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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low caloric diet

low caloric diet (1200cal/day)

Group Type PLACEBO_COMPARATOR

low calolric diet

Intervention Type DIETARY_SUPPLEMENT

low caloric diet (1200cal/day)

cryolipolysis

cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device

Group Type ACTIVE_COMPARATOR

3max cool shaping device

Intervention Type DEVICE

cryolipolysis sessions are applied on abdomen area each session for 40 min. each

low calolric diet

Intervention Type DIETARY_SUPPLEMENT

low caloric diet (1200cal/day)

Interventions

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3max cool shaping device

cryolipolysis sessions are applied on abdomen area each session for 40 min. each

Intervention Type DEVICE

low calolric diet

low caloric diet (1200cal/day)

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

20 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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fahema me okiel, phd

Role: STUDY_DIRECTOR

Cairo University

amal mo youssef, phd

Role: STUDY_CHAIR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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miral mo saleh, md

Role: CONTACT

01200678845 ext. +012

Facility Contacts

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miral s mohamed, md

Role: primary

01200678845 ext. +012

Other Identifiers

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ECVAPP

Identifier Type: -

Identifier Source: org_study_id

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