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

February 21, 2021 updated by: Miral Saleh Mohamed, Cairo University
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

90

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
    • Giza
      • Cairo, Giza, Egypt, 11865
        • Recruiting
        • Cairo University
        • Contact:
        • Principal Investigator:
          • fahema me okiel, phd

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

15 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cryolipolysis
3max cool shaping device is administered 3 times for each patient, one session every 6 weeks, each session is 40 minutes.
Device: cryolipolysis(3 max cool shaping)
cryolioplysis applied over abdomen area
Experimental: 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.
Device: Treadmill (jkexer focus 8020A)
aerobic training ( high intensity interval training)
Active Comparator: treadmill+cryolipolysis
aerobic training 3 times per week and cryolipolysis once every 6 weeks
Device: cryolipolysis(3 max cool shaping)
cryolioplysis applied over abdomen area
Device: Treadmill (jkexer focus 8020A)
aerobic training ( high intensity interval training)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HOMA IR
Time Frame: 3 months
blood test
3 months
weight
Time Frame: up to 3 months
anthropometric measure measured in kilogram (kg)
up to 3 months
fat percentage
Time Frame: up to 3 months
overall body fat percentage measured by body fat analyzer in percentage (%)
up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
waist circumference
Time Frame: up to 3 months
anthropometric measurement measured in centimeter (cm)
up to 3 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Director: 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 23, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHCIBPP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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