Abdominal ObesityNCT05852652
Combination of Cryolipolysis and Aerobic Exercise in Reducing Abdominal Fat
A study testing cryolipolysis and aerobic exercise in people with Abdominal Obesity, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is To investigate the adding effect of Cryolipolysis to aerobic exercise with low caliorie diet on waist-to-hip ratio , ultrasonography, body mass index and skin fold of subcutaneous fat tissue in abdominal adiposity in obese subjects Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- cryolipolysis and aerobic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2022to 22 Feb 2023
- 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of the subjects range from (30-40)kg/m2
- subjects have abdominal adiposity
Who cannot join
- patients with liver and kidney diseases
- patients who have sensitivity to cold
- patients who have auto-immune disease
- patients after caesarean section
- impaired peripheral circulation
- Raynauds disease
Show all 9Show fewer
- pregnant or lactating women within 6 months
- paroxysmal cold hemogobulinemia
- individuals who had metabolic derangement such as type 2 dibetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Combination Between Cryolipolysis and Aerobic Exercise in Reducing Abdominal Adiposity in Obese Subjects
The purpose of the study is To investigate the adding effect of Cryolipolysis to aerobic exercise with low caliorie diet on waist-to-hip ratio , ultrasonography, body mass index and skin fold of subcutaneous fat tissue in abdominal adiposity in obese subjects
Read the detailed description
Obesity is a serious disease marked by an increase in body weight of at least 20% over the ideal weight due to an accumulation of body fat.
The prevalence of obesity has hit epidemic levels over the past few decades, and numerous obesity-related illnesses, including heart conditions, certain types of cancer, and diabetes, have risen concurrently. Weight loss through lifestyle modification, including a hypocaloric diet and/or increased physical exercise, along with behavioural techniques to support these changes, is the basis for treating or preventing these diseases through therapeutic intervention. Such methods rarely result in an obese person reaching a normal body weight because the typical weight reduction from lifestyle change is between 5 and 10% of baseline weight.
Recently, studies have used numerous devices, including cavitation, radiofrequency, cryolypolysis, and other many devices, according to the World Health Organization, to solve this issue.
The FDA has approved the cryolipolysis device for cutaneous cooling as well as a number of other uses. Cryolipolysis is a novel non-invasive technique for the selective reduction of fat cells with controlled, localised cooling.
Clinicians use the waist measurement and waist-to-hip ratio to assess abdominal obesity. These actions have a clear correlation to many vascular diseases, including atherosclerosis and the risk of developing acute coronary syndromes.
Typically, low-calorie diets are low in fat ( 30% of energy intake), high in carbohydrates (55-60% of total daily energy consumption), and energy-reduced (deficit of 2100-4200 kJ/d: ) minimum of 4200-5040 kJ/d for women and 5040- 5880 kJ/d for men) Due to the acutely high energy cost and ability to increase fat utilization, aerobic exercise is frequently recommended in conjunction with calorie restriction. Numerous studies examined the effects of modest caloric restriction alone or in combination with aerobic exercise.According to studies, a walk/jog programme enhanced body fat reduction compared to a group that only followed a diet.
There is a gap in the literature regarding combining cryolipolysis and aerobic exercise for losing weight, particularly abdominal adiposity, despite the fact that numerous studies have supported the efficacy of each on weight loss. Therefore, the goal of this research is to ascertain whether losing abdominal adiposity would be more successful when cryolipolysis and aerobic exercise were combined.
- Conditions
- Abdominal Obesity
- Being tested
- cryolipolysis and aerobic exercise
- Keywords
- cryolipolysis,low calorie diet and areobic exercise
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryolipolysis and aerobic exerciseDevice
the patients in this arm adjusted low calorie diet . According to the Recommended Dietary Intake (RDI), the low-calorie diet plan with three carefully calculated meals had a balanced macronutrient quantity of carbohydrate and protein, was low in fat, and was abundant in fruits, vegetables, and dietary fibres.
they got two cryolipolysis sessions,one session in the month ,they got two sessions in two months,then took our outcome measures with walking 60 minutes in the park
| Study group | Role | What they receive |
|---|---|---|
| cryolipolysis and aerobic exercise | Experimental | in this arm we combined between Three Max cool shaping Cryolipolysis device (ESM-8l00MO; EunSung global, Korea) was utilised. Vacuum controllable heads with cold temperatures ranging from (-10to 5)°C were adjusted according to each patient's tolerance, after careful patient sensation examination and vital sign evaluation before and after each session ,they got two sessions and walked from 30 to 60 minutes in nearby park.Two Cryolipolysis treatments totaling 45 minutes each were administered to each patient in the experimental group at the hypogastrium region, 5 cm below the umbilicus, using an anti-freezing membrane to prevent cold burn, in order to conduct the treatment Receives: Device: cryolipolysis and aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
the waist-to-hip ratio
by tape measurment
Measured: 2 months
abdominal skin fold
by fat caliper
Measured: 2 months
body mass index
by equation of world health organization
Measured: 2 months
fat thickness
by ultrasonography
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start12 Dec 2022
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ebrahim Elsayed Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852652
- Sponsor's protocol ID
- cryolipolysis
- Status last verified
- May 2023
- First submitted
- 23 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combination Between Cryolipolysis and Aerobic Exercise in Reducing Abdominal Adiposity in Obese Subjects
- ClinicalTrials.gov ID
- NCT05852652
- Acronym / sponsor ID
- cryolipolysis
- Conditions
- Abdominal Obesity
- Keywords
- cryolipolysis,low calorie diet and areobic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 10 May 2023 (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.
The purpose of the study is To investigate the adding effect of Cryolipolysis to aerobic exercise with low caliorie diet on waist-to-hip ratio , ultrasonography, body mass index and skin fold of subcutaneous fat tissue in abdominal adiposity in obese subjects
Detailed description
Obesity is a serious disease marked by an increase in body weight of at least 20% over the ideal weight due to an accumulation of body fat.
The prevalence of obesity has hit epidemic levels over the past few decades, and numerous obesity-related illnesses, including heart conditions, certain types of cancer, and diabetes, have risen concurrently. Weight loss through lifestyle modification, including a hypocaloric diet and/or increased physical exercise, along with behavioural techniques to support these changes, is the basis for treating or preventing these diseases through therapeutic intervention. Such methods rarely result in an obese person reaching a normal body weight because the typical weight reduction from lifestyle change is between 5 and 10% of baseline weight.
Recently, studies have used numerous devices, including cavitation, radiofrequency, cryolypolysis, and other many devices, according to the World Health Organization, to solve this issue.
The FDA has approved the cryolipolysis device for cutaneous cooling as well as a number of other uses. Cryolipolysis is a novel non-invasive technique for the selective reduction of fat cells with controlled, localised cooling.
Clinicians use the waist measurement and waist-to-hip ratio to assess abdominal obesity. These actions have a clear correlation to many vascular diseases, including atherosclerosis and the risk of developing acute coronary syndromes.
Typically, low-calorie diets are low in fat ( 30% of energy intake), high in carbohydrates (55-60% of total daily energy consumption), and energy-reduced (deficit of 2100-4200 kJ/d: ) minimum of 4200-5040 kJ/d for women and 5040- 5880 kJ/d for men) Due to the acutely high energy cost and ability to increase fat utilization, aerobic exercise is frequently recommended in conjunction with calorie restriction. Numerous studies examined the effects of modest caloric restriction alone or in combination with aerobic exercise.According to studies, a walk/jog programme enhanced body fat reduction compared to a group that only followed a diet.
There is a gap in the literature regarding combining cryolipolysis and aerobic exercise for losing weight, particularly abdominal adiposity, despite the fact that numerous studies have supported the efficacy of each on weight loss. Therefore, the goal of this research is to ascertain whether losing abdominal adiposity would be more successful when cryolipolysis and aerobic exercise were combined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cryolipolysis and aerobic exercise | Experimental | Device: cryolipolysis and aerobic exercisein this arm we combined between Three Max cool shaping Cryolipolysis device (ESM-8l00MO; EunSung global, Korea) was utilised. Vacuum controllable heads with cold temperatures ranging from (-10to 5)°C were adjusted according to each patient's tolerance, after careful patient sensation examination and vital sign evaluation before and after each session ,they got two sessions and walked from 30 to 60 minutes in nearby park.Two Cryolipolysis treatments totaling 45 minutes each were administered to each patient in the experimental group at the hypogastrium region, 5 cm below the umbilicus, using an anti-freezing membrane to prevent cold burn, in order to conduct the treatment |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index of the subjects range from (30-40)kg/m2
- subjects have abdominal adiposity
Key exclusion criteria (9 listed)
- patients with liver and kidney diseases
- patients who have sensitivity to cold
- patients who have auto-immune disease
- patients after caesarean section
- impaired peripheral circulation
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 and aerobic exercisethe patients in this arm adjusted low calorie diet . According to the Recommended Dietary Intake (RDI), the low-calorie diet plan with three carefully calculated meals had a balanced macronutrient quantity of carbohydrate and protein, was low in fat, and was abundant in fruits, vegetables, and dietary fibres. they got two cryolipolysis sessions,one session in the month ,they got two sessions in two months,then took our outcome measures with walking 60 minutes in the park | Device | cryolipolysis and aerobic exercise |
Primary outcome
the waist-to-hip ratio
Time frame: 2 months
by tape measurment
abdominal skin fold
Time frame: 2 months
by fat caliper
body mass index
Time frame: 2 months
by equation of world health organization
fat thickness
Time frame: 2 months
by ultrasonography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and aerobic exercise in people with Abdominal Obesity, 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 10 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the waist-to-hip ratio (time frame: 2 months). The study lists 4 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 10 May 2023.