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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04745338
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial

Condition or DiseaseIntervention/TreatmentPhase
  • Device: 3max cool shaping device
  • Dietary Supplement: low calolric diet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome 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

ArmIntervention/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

Device: 3max cool shaping device
cryolipolysis sessions are applied on abdomen area each session for 40 min. each

Dietary Supplement: low calolric diet
low caloric diet (1200cal/day)

Outcome Measures

Primary Outcome Measures

  1. Visceral adiposity index [3 months]

    indicator of adipose tissue distribution

Secondary Outcome Measures

  1. weight [up to 3 months]

    anthropometric measurement by kilogram (kg)

  2. waist circumference [up to 3 months]

    anthropometric measurement by centimeter (cm)

  3. high density lipoprotein [up to 3 months]

    blood test

  4. serum triglyceride level [up to 3months]

    blood test

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 28 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cairo UniversityCairoEgypt14788

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: fahema me okiel, phd, Cairo University
  • Study Chair: 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:
NCT04745338
Other Study ID Numbers:
  • ECVAPP
First Posted:
Feb 9, 2021
Last Update Posted:
Feb 9, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2021