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NCT04744896 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04744896
Other study ID # EHCIBPP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date February 28, 2022

Study information
Verified date February 2021
Source Cairo University
Contact miral saleh, md
Phone 01200678845
Email marmooramido@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date February 28, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 28 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• cryolipolysis(3 max cool shaping)
cryolioplysis applied over abdomen area
• Treadmill (jkexer focus 8020A)
aerobic training ( high intensity interval training)

Locations
Country Name City State
Egypt Cairo University Cairo Giza

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary HOMA IR blood test 3 months
Primary weight anthropometric measure measured in kilogram (kg) up to 3 months
Primary fat percentage overall body fat percentage measured by body fat analyzer in percentage (%) up to 3 months
Secondary waist circumference anthropometric measurement measured in centimeter (cm) up to 3 months
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Withdrawn NCT01638988 - Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin Phase 3
Not yet recruiting NCT00883259 - Metformin and Gestational Diabetes in High-risk Patients: a RCTs Phase 4
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Recruiting NCT01431352 - Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS) N/A
Completed NCT00989781 - Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome N/A