NCT04744896

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 3, 2021

Last Update Submit

February 21, 2021

Conditions

Polycystic Ovary SyndromeHyperinsulinism

Keywords

pco

Outcome Measures

Primary Outcomes (3)

  • HOMA IR

    blood test

    3 months

  • weight

    anthropometric measure measured in kilogram (kg)

    up to 3 months

  • fat percentage

    overall body fat percentage measured by body fat analyzer in percentage (%)

    up to 3 months

Secondary Outcomes (1)

  • waist circumference

    up to 3 months

Study Arms (3)

cryolipolysis

EXPERIMENTAL

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)

treadmill

EXPERIMENTAL

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)

treadmill+cryolipolysis

ACTIVE COMPARATOR

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

Device: cryolipolysis(3 max cool shaping)Device: Treadmill (jkexer focus 8020A)

Interventions

cryolipolysis(3 max cool shaping)DEVICE

cryolioplysis applied over abdomen area

cryolipolysistreadmill+cryolipolysis
Treadmill (jkexer focus 8020A)DEVICE

aerobic training ( high intensity interval training)

treadmilltreadmill+cryolipolysis

Eligibility Criteria

Age17 Years - 28 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women diagnosed with polycystic ovarian syndrome
  • age ranges from 17-28 years
  • body mass index ranges 25-30 Kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 11865, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeHyperinsulinism

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • amal mo youssef, phd

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

miral saleh, md

CONTACT

01200678845marmooramido@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: cryolipolysis treadmill cryolipolysis + treadmill
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 9, 2021

Study Start

March 1, 2021

Primary Completion

January 30, 2022

Study Completion

February 28, 2022

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

EG(1)