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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06024018
Other study ID # P.T.REC/012/003755
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 1, 2023

Study information

Verified date August 2023
Source Cairo University
Contact Ali MA Ismail, lecturer
Phone 01005154209
Email ali.mohamed@pt.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Egypt Cairo Unoversity Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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