Back to resultsEffect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3max cool shaping device
low calolric diet
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
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
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
low caloric diet
cryolipolysis
Arm Description
low caloric diet (1200cal/day)
cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device
Outcomes
Primary Outcome Measures
Visceral adiposity index
indicator of adipose tissue distribution
Secondary Outcome Measures
weight
anthropometric measurement by kilogram (kg)
waist circumference
anthropometric measurement by centimeter (cm)
high density lipoprotein
blood test
serum triglyceride level
blood test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04745338
Brief Title
Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients
Official Title
Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low caloric diet
Arm Type
Placebo Comparator
Arm Description
low caloric diet (1200cal/day)
Arm Title
cryolipolysis
Arm Type
Active Comparator
Arm Description
cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device
Intervention Type
Device
Intervention Name(s)
3max cool shaping device
Intervention Description
cryolipolysis sessions are applied on abdomen area each session for 40 min. each
Intervention Type
Dietary Supplement
Intervention Name(s)
low calolric diet
Intervention Description
low caloric diet (1200cal/day)
Primary Outcome Measure Information:
Title
Visceral adiposity index
Description
indicator of adipose tissue distribution
Time Frame
3 months
Secondary Outcome Measure Information:
Title
weight
Description
anthropometric measurement by kilogram (kg)
Time Frame
up to 3 months
Title
waist circumference
Description
anthropometric measurement by centimeter (cm)
Time Frame
up to 3 months
Title
high density lipoprotein
Description
blood test
Time Frame
up to 3 months
Title
serum triglyceride level
Description
blood test
Time Frame
up to 3months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
it is carried on women with dysfunction in ovaries
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
miral mo saleh, md
Phone
01200678845
Ext
+012
Email
marmooramido@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fahema me okiel, phd
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
amal mo youssef, phd
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
14788
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients
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