Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06024018
Status:
UNKNOWN
Last Update Posted:
2023-09-05
First Post:
2023-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056128', 'term': 'Obesity, Abdominal'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-09-04', 'lastUpdatePostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'subcutaenous abdominal fat thickness', 'timeFrame': '12 weeks', 'description': 'it will be measured using ultrasonography'}], 'secondaryOutcomes': [{'measure': 'visceral abdominal fat thickness', 'timeFrame': '12 weeks', 'description': 'it will be measured using ultrasonography'}, {'measure': 'body mass index', 'timeFrame': '12 weeks', 'description': 'it will be measured at morning with empty stomach and bladder'}, {'measure': 'waist circumference', 'timeFrame': '12 weeks', 'description': 'it will be measured using inelastic tape'}, {'measure': 'cortisol', 'timeFrame': '12 weeks', 'description': 'it is a stress hormone'}, {'measure': 'high density lipoprotein', 'timeFrame': '12 weeks', 'description': 'it will be measured in serum'}, {'measure': 'low density lipoprotein', 'timeFrame': '12 weeks', 'description': 'it will be measured in serum'}, {'measure': 'triglycerides', 'timeFrame': '12 weeks', 'description': 'it will be measured in serum'}, {'measure': 'cholesterol', 'timeFrame': '12 weeks', 'description': 'it will be measured in serum'}, {'measure': 'appearance of abdomen subscale of Body Q questionnaire', 'timeFrame': '12 weeks', 'description': 'BODY-Q provides a set of scales focusing on topics that are relevant to weight'}, {'measure': 'health related-quality-of-life subscale of Body Q questionnaire', 'timeFrame': '12 weeks', 'description': 'it provids questions related to body image , physical function , psychological function , sexual function'}, {'measure': 'eating related concerns subscale of Body Q questionnaire', 'timeFrame': '12 weeks', 'description': 'it provids questions related to eating behavior , expectations weight loss'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Obesity']}, 'descriptionModule': {'briefSummary': "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", 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'based on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men with central obesity\n* BMI 30-34.9 kg/m2\n\nExclusion Criteria:\n\n* metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses'}, 'identificationModule': {'nctId': 'NCT06024018', 'briefTitle': 'Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of High Intensity Electromagnetic Body Shaping in Obese Men', 'orgStudyIdInfo': {'id': 'P.T.REC/012/003755'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'first group', 'description': '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', 'interventionNames': ['Device: high intensity electromagnetic technology device, diet restriction, and walking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'second group', 'description': '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.', 'interventionNames': ['Behavioral: diet restriction and walking']}], 'interventions': [{'name': 'high intensity electromagnetic technology device, diet restriction, and walking', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['first group']}, {'name': 'diet restriction and walking', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['second group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ali Ismail, lecturer', 'role': 'CONTACT', 'email': 'allooka2012@gmail.com', 'phone': '01005154209'}, {'name': 'EBTEHAL ATEF RAMADAN AFYA', 'role': 'CONTACT', 'email': 'dr.ebtehalpt@yahoo.com', 'phone': '020 102 466 6329'}], 'facility': 'Cairo Unoversity', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Ali MA Ismail, lecturer', 'role': 'CONTACT', 'email': 'ali.mohamed@pt.cu.edu.eg', 'phone': '01005154209'}, {'name': 'ebtahal ATEF RAMADAN Afya', 'role': 'CONTACT', 'email': 'dr.ebtehalpt@yahoo.com', 'phone': '02 1024666329'}], 'overallOfficials': [{'name': 'Ali MA Ismail, lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University', 'investigatorFullName': 'Ali Mohamed Ali ismail', 'investigatorAffiliation': 'Cairo University'}}}}