Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men

September 4, 2023 updated by: Ali Mohamed Ali ismail, Cairo University

Efficacy of High Intensity Electromagnetic Body Shaping in Obese Men

high intensity focused electromagnetic technology's secondary effects are observed in the fat (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8 In addition, after the application of the high intensity electromagnetic technique, there is an increase in the rapid release of free fatty acids, so it can be used in weight loss

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

sixty obese males will be grouped to: first group (30 males) and second group (30 males). first and second groups will undergo dietary caloric restriction (i.e low calorie diet) and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. only the first group will will undergo high intensity electromagnetic technique on abdomen of males which will be 3 sessions per week for 3 months

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • men with central obesity
  • BMI 30-34.9 kg/m2

Exclusion Criteria:

  • metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: first group
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months
Device: high intensity electromagnetic technology device, diet restriction, and walking
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months
Active Comparator: second group
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.
Behavioral: diet restriction and walking
thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subcutaenous abdominal fat thickness
Time Frame: 12 weeks
it will be measured using ultrasonography
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visceral abdominal fat thickness
Time Frame: 12 weeks
it will be measured using ultrasonography
12 weeks
body mass index
Time Frame: 12 weeks
it will be measured at morning with empty stomach and bladder
12 weeks
waist circumference
Time Frame: 12 weeks
it will be measured using inelastic tape
12 weeks
cortisol
Time Frame: 12 weeks
it is a stress hormone
12 weeks
high density lipoprotein
Time Frame: 12 weeks
it will be measured in serum
12 weeks
low density lipoprotein
Time Frame: 12 weeks
it will be measured in serum
12 weeks
triglycerides
Time Frame: 12 weeks
it will be measured in serum
12 weeks
cholesterol
Time Frame: 12 weeks
it will be measured in serum
12 weeks
appearance of abdomen subscale of Body Q questionnaire
Time Frame: 12 weeks
BODY-Q provides a set of scales focusing on topics that are relevant to weight
12 weeks
health related-quality-of-life subscale of Body Q questionnaire
Time Frame: 12 weeks
it provids questions related to body image , physical function , psychological function , sexual function
12 weeks
eating related concerns subscale of Body Q questionnaire
Time Frame: 12 weeks
it provids questions related to eating behavior , expectations weight loss
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Ali MA Ismail, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003755

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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