Effect Of Cryolipolysis On Visceral Adiposity Index In Po... | NCT04745338

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

NCT04745338

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 9, 2021Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Polycystic Ovary Syndrome

Interventions

3max cool shaping device
low calolric diet

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Estimated

Primary Completion Date

Jan 30, 2022Estimated

Completion Date

Feb 28, 2022Estimated

First Submitted Date

Feb 3, 2021

First Submission Date that Met QC Criteria

Feb 4, 2021

First Posted Date

Feb 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2021

Last Update Posted Date

Feb 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
low caloric diet	Placebo Comparator	low caloric diet (1200cal/day)	Dietary Supplement: low calolric diet
cryolipolysis	Active Comparator	cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device	Device: 3max cool shaping device Dietary Supplement: low calolric diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3max cool shaping device	Device	cryolipolysis sessions are applied on abdomen area each session for 40 min. each	cryolipolysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visceral adiposity index	indicator of adipose tissue distribution	3 months

Secondary Outcomes

Measure	Description	Time Frame
weight	anthropometric measurement by kilogram (kg)	up to 3 months
waist circumference	anthropometric measurement by centimeter (cm)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

it is carried on women with dysfunction in ovaries

Minimum Age

20 Years

Maximum Age

28 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
miral mo saleh, md	Contact	01200678845	+012	marmooramido@gmail.com

Overall Officials

Name	Affiliation	Role
fahema me okiel, phd	Cairo University	Study Director
amal mo youssef, phd	Cairo University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University	Recruiting	Cairo		14788	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided