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

Primary Purpose

Polycystic Ovary Syndrome, Hyperinsulinism

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cryolipolysis(3 max cool shaping)
Treadmill (jkexer focus 8020A)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring pco

Eligibility Criteria

17 Years - 28 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

cryolipolysis

treadmill

treadmill+cryolipolysis

Arm Description

3max cool shaping device is administered 3 times for each patient, one session every 6 weeks, each session is 40 minutes.

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.

aerobic training 3 times per week and cryolipolysis once every 6 weeks

Outcomes

Primary Outcome Measures

HOMA IR
blood test
weight
anthropometric measure measured in kilogram (kg)
fat percentage
overall body fat percentage measured by body fat analyzer in percentage (%)

Secondary Outcome Measures

waist circumference
anthropometric measurement measured in centimeter (cm)

Full Information

First Posted
February 3, 2021
Last Updated
February 21, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04744896
Brief Title
Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients
Official Title
Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Hyperinsulinism
Keywords
pco

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
cryolipolysis treadmill cryolipolysis + treadmill
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cryolipolysis
Arm Type
Experimental
Arm Description
3max cool shaping device is administered 3 times for each patient, one session every 6 weeks, each session is 40 minutes.
Arm Title
treadmill
Arm Type
Experimental
Arm Description
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.
Arm Title
treadmill+cryolipolysis
Arm Type
Active Comparator
Arm Description
aerobic training 3 times per week and cryolipolysis once every 6 weeks
Intervention Type
Device
Intervention Name(s)
cryolipolysis(3 max cool shaping)
Intervention Description
cryolioplysis applied over abdomen area
Intervention Type
Device
Intervention Name(s)
Treadmill (jkexer focus 8020A)
Intervention Description
aerobic training ( high intensity interval training)
Primary Outcome Measure Information:
Title
HOMA IR
Description
blood test
Time Frame
3 months
Title
weight
Description
anthropometric measure measured in kilogram (kg)
Time Frame
up to 3 months
Title
fat percentage
Description
overall body fat percentage measured by body fat analyzer in percentage (%)
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
waist circumference
Description
anthropometric measurement measured in centimeter (cm)
Time Frame
up to 3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
miral saleh, md
Phone
01200678845
Ext
+010
Email
marmooramido@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
amal mo youssef, phd
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
State/Province
Giza
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
miral s mohamed, md
Phone
01200678845
Ext
+012
Email
marmooramido@gmail.com
First Name & Middle Initial & Last Name & Degree
fahema me okiel, phd

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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