Polycystic Ovary SyndromeNCT04744896
Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients
A study testing cryolipolysis(3 max cool shaping) and Treadmill (jkexer focus 8020A) in people with Polycystic Ovary Syndrome and Hyperinsulinism, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 17 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Hyperinsulinism
- What is being tested?
- cryolipolysis(3 max cool shaping) and Treadmill (jkexer focus 8020A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 28 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- women diagnosed with polycystic ovarian syndrome
- age ranges from 17-28 years
- body mass index ranges 25-30 Kg/m2
Who cannot join
- Diabetic patients.
- Women with BMI>30
- Women having circulatory dysfunction.
- Women with respiratory or cardiac disease
- liver disease.
- Skin disease .
Show all 10Show fewer
- Previous abdominal or uterine surgery
- any medications affecting hormones
- any physical impairments
- Physical impairment
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, Giza Governorate, 11865
miral s mohamed, md, 01200678845 ext. +012, marmooramido@gmail.com
fahema me okiel, phd
About this study
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
Read the 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
- Conditions
- Polycystic Ovary Syndrome, Hyperinsulinism
- Being tested
- cryolipolysis(3 max cool shaping), Treadmill (jkexer focus 8020A)
- Keywords
- pco
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryolipolysis(3 max cool shaping)Device
cryolioplysis applied over abdomen area
Treadmill (jkexer focus 8020A)Device
aerobic training ( high intensity interval training)
| Study group | Role | What they receive |
|---|---|---|
| cryolipolysis | Experimental | 3max cool shaping device is administered 3 times for each patient, one session every 6 weeks, each session is 40 minutes. Receives: 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. Receives: Device: Treadmill (jkexer focus 8020A) |
| treadmill+cryolipolysis | Active comparator | aerobic training 3 times per week and cryolipolysis once every 6 weeks Receives: Device: cryolipolysis(3 max cool shaping); Device: Treadmill (jkexer focus 8020A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA IR
blood test
Measured: 3 months
weight
anthropometric measure measured in kilogram (kg)
Measured: up to 3 months
fat percentage
overall body fat percentage measured by body fat analyzer in percentage (%)
Measured: up to 3 months
Secondary outcomes (1)
waist circumference
anthropometric measurement measured in centimeter (cm)
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cryolipolysis treadmill cryolipolysis + treadmill
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miral Saleh Mohamed, Cairo University
- Investigators
- amal mo youssef, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744896
- Sponsor's protocol ID
- EHCIBPP
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Combined Cryolipolysis And High Intensity Interval Training On Insulin Resistance And Body Composition In Polycystic Ovarian Patients
- ClinicalTrials.gov ID
- NCT04744896
- Acronym / sponsor ID
- EHCIBPP
- Conditions
- Polycystic Ovary Syndrome, Hyperinsulinism
- Keywords
- pco
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- cryolipolysis treadmill cryolipolysis + treadmill
| Arm | Type | Receives |
|---|---|---|
| cryolipolysis | Experimental | Device: cryolipolysis(3 max cool shaping)3max cool shaping device is administered 3 times for each patient, one session every 6 weeks, each session is 40 minutes. |
| treadmill | Experimental | Device: Treadmill (jkexer focus 8020A)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. |
| treadmill+cryolipolysis | Active comparator | Device: cryolipolysis(3 max cool shaping), Device: Treadmill (jkexer focus 8020A)aerobic training 3 times per week and cryolipolysis once every 6 weeks |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- women diagnosed with polycystic ovarian syndrome
- age ranges from 17-28 years
- body mass index ranges 25-30 Kg/m2
Key exclusion criteria (10 listed)
- Diabetic patients.
- Women with BMI>30
- Women having circulatory dysfunction.
- Women with respiratory or cardiac disease
- liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryolipolysis(3 max cool shaping)cryolioplysis applied over abdomen area | Device | cryolipolysis, treadmill+cryolipolysis |
| Treadmill (jkexer focus 8020A)aerobic training ( high intensity interval training) | Device | treadmill, treadmill+cryolipolysis |
Primary outcome
HOMA IR
Time frame: 3 months
blood test
weight
Time frame: up to 3 months
anthropometric measure measured in kilogram (kg)
fat percentage
Time frame: up to 3 months
overall body fat percentage measured by body fat analyzer in percentage (%)
1 secondary outcome
waist circumference
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
amal mo youssef, phd study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryolipolysis(3 max cool shaping) and Treadmill (jkexer focus 8020A) in people with Polycystic Ovary Syndrome and Hyperinsulinism, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact miral saleh, md (01200678845 ext. +010, marmooramido@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA IR (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.