Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT05895435
Status:
UNKNOWN
Last Update Posted:
2023-06-08
First Post:
2023-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-10-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2023-05-31', 'studyFirstSubmitQcDate': '2023-05-31', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total cholestrol and HDL and LDL and triglycerides and VLDL by blood analysis', 'timeFrame': '8 week', 'description': 'measure before and after tratement programm'}], 'secondaryOutcomes': [{'measure': 'waist circumferance using tape measurment', 'timeFrame': '8 week', 'description': 'measure before and after tratement'}, {'measure': 'body mass index', 'timeFrame': '8 week', 'description': 'measure before and after tratement'}, {'measure': 'weight', 'timeFrame': '8 week', 'description': 'measure before and after tratement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Show Positive Effect of Radiofrequancy on Postmenopausal Adipose Tissue']}, 'referencesModule': {'availIpds': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/12841881/', 'type': 'Study Protocol'}], 'references': [{'pmid': '12841881', 'type': 'BACKGROUND', 'citation': 'Guthrie JR, Dennerstein L, Taffe JR, Donnelly V. Health care-seeking for menopausal problems. Climacteric. 2003 Jun;6(2):112-7.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/news-room/fact-sheets/detail/menopause', 'label': 'data obtain through the study may be provided to a qualified resarcher'}]}, 'descriptionModule': {'briefSummary': '* Menopause is associated with a redistribution of adipose tissue towards central adiposity, known to cause insulin resistance. It was found that menopause was associated with changes in adipose tissue phenotype related to metabolic dysfunction. In subcutaneous adipose tissue (SAT)\n* The radiofrequency uses high-frequency electromagnetic waves to produce heat at the cutaneous and the subcutaneous levels. The mechanism of action, through the vibration of water molecules, transforms the electromagnetic energy into thermal. The heat generated by conversion occurs under 30 kHz to 300 MHz, and the most frequently used frequency is set between 0.5 and 1.5 MHz. The RF mechanism of fat reduction occurs by the generation of thermal stimulation of adipocyte metabolism, occurring through enzymatic degradation by lipase-mediated triglycerides, apoptosis, and adipocyte rupture and the objective of study to show the positive effect of radiofrequancy on postmenopausal adipose tissue', 'detailedDescription': "About 90% of menopausal women experience some amount of weight gain. It is a natural and common aspect of getting older. It occurs because the body mass increases, as a result of fat deposits. However, weight gain associated with menopause typically involves increased amounts of fat around the abdomen. On an average, women gain between 8-10 kilogram between the ages of 45 and 55, the stage in life when menopause occurs. This extra weight generally does not evenly distribute itself throughout a woman's body. The weight tends instead to accumulate around the abdomen or thighs (Singh et al., 2013).\n\nPostmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and android fat redistribution it is mostly attributed to estrogen depletion though other factors such as chronological aging and decline in physical activity play a significant role. The deleterious health consequences of obesity and visceral fat deposition after menopause encompass a variety of problems; from dyslipidemia and metabolic syndrome to increased risk of cardiovascular disease (CVD), osteoporosis, malignancies and mortality (Stachowiak et al., 2015) This emphasizes the need of effective methods for treating central adiposity in post-menopausal woman. No prior studies have investigated the effect of radiofrequency on adipose tissue. So this may add a new physical therapy method for treating this problem."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1-Their ages will be ranged from 45 to 60 years 2- BMI \\> 25 kg/m² and \\< 35 kg/m². 3- Waist circumference more than 88cm\n\nExclusion Criteria:\n\n* 1-Cancer. 2-Renal failure 3-tumors 4-Hepatic diseases 5-skin disease that prevent the use of radiofrequancy'}, 'identificationModule': {'nctId': 'NCT05895435', 'briefTitle': 'THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE', 'orgStudyIdInfo': {'id': 'the effect of radiofrequancy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'first group', 'description': 'Group (A) (Control Group):\n\nIt will be consisted of 30 patients who will receive aerobic exercise and diet for 8 successive weeks 2 sessions per week.', 'interventionNames': ['Other: aerobic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'second group', 'description': 'Group (B) (Study Group):\n\nIt will be consisted of 30 patients who will receive aerobic exercise and diet and radiofrequency for 8 successive weeks 2 sessions per week.', 'interventionNames': ['Device: radiofrequancy', 'Other: aerobic exercise']}], 'interventions': [{'name': 'radiofrequancy', 'type': 'DEVICE', 'description': '* Power of device: 150 W\n* Duration of the session: 40 minutes\n* Frequency: 2 sessions per week for 8 week.\n* Heating temperature: According to patient tolerance.', 'armGroupLabels': ['second group']}, {'name': 'aerobic exercise', 'type': 'OTHER', 'description': 'The program include five minutes for warming-up in the form of range of motion and stretching exercises, thirty minutes of walking on treadmill with high speed (60-70% of maximum heart rate) and five minutes of cooling down (on treadmill with low speed and without inclination', 'armGroupLabels': ['first group', 'second group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'mahmoud adel darahem', 'role': 'CONTACT', 'email': 'mahmouddarahem2023@gamil.com', 'phone': '01028911100'}, {'name': 'afaf mohamed botla', 'role': 'CONTACT', 'email': 'drafafmohamed@cu.edu.eg', 'phone': '01283126608'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'effect of radiofrequancy on postmenopausal adipose tissue', 'investigatorFullName': 'Mahmoud Adel Elasyed Darahem', 'investigatorAffiliation': 'Cairo University'}}}}