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

February 4, 2021 updated by: Miral Saleh Mohamed, Cairo University
this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 14788
        • Recruiting
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: low caloric diet
low caloric diet (1200cal/day)
Dietary supplement: low calolric diet
low caloric diet (1200cal/day)
Active Comparator: cryolipolysis
cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device
Dietary supplement: low calolric diet
low caloric diet (1200cal/day)
Device: 3max cool shaping device
cryolipolysis sessions are applied on abdomen area each session for 40 min. each

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight
Time Frame: up to 3 months
anthropometric measurement by kilogram (kg)
up to 3 months
waist circumference
Time Frame: up to 3 months
anthropometric measurement by centimeter (cm)
up to 3 months
high density lipoprotein
Time Frame: up to 3 months
blood test
up to 3 months
serum triglyceride level
Time Frame: up to 3months
blood test
up to 3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: fahema me okiel, phd, Cairo University
  • Study Chair: amal mo youssef, phd, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

January 30, 2022

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECVAPP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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