Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05818293
Status:
UNKNOWN
Last Update Posted:
2023-07-12
First Post:
2023-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'will be blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1\\) Radiofrequency (RF):\n\n* Twenty six post-menopausal women in group (A) will receive RF, is a healthy and effective method for reducing the abdominal obesity regulation of insulin secretion, and enhance quality of life of post-menopausal women. It will be directed to group (A) only .\n* Group (A) will receive 30 minutes on the abdominal area, twice per week, as recommended in the standard treatment protocol by the manufacturer. Group (B) (control group) will receive regular diet habits only.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EFFECT OF RADIOFRQUENCY ON INSULIN RESISTANCE IN OBESE POST MENOPAUSAL WOMEN EFFECT OF RADIOFRQUENCY ON INSULIN RESISTANCE IN OBESE POST MENOPAUSAL WOMEN effect of radiofrequency on insulin resistance in obese post menopausal women', 'timeFrame': '4 months', 'description': 'RF will use to reduce subcutaneous fat in abdomen and buttocks. he outcome measures to assess the insulin resistance by Homeostasis Model Assessment (HOMA), abdominal obesity by abdominal ultrasound and waist \\\\hip ratio.\n\n1. The Homeostasis Model Assessment (HOMA) :\n\n Is a model of interactions between glucose and insulin dynamics that is then used to predict fasting steady-state glucose and insulin concentrations for a wide range of possible combinations of insulin resistance and β-cell function. The model assumes a feedback loop between the liver and β-cell .\n2. Abdominal Ultrasound: To assess abdominal fat for all participants before and after treatment program.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'insulin resistance as the prime factor linking visceral obesity with adverse metabolic changes. Analysis of abdominal obesity by imaging studies have generally reached the conclusion that it is the excess of intra-abdominal or visceral adipose tissue .Multiple environmental and genetic factors are thought to influence the manifestation of abdominal obesity. The expanded adipose tissue contributes to expose the liver to high concentrations of free fatty acids (FFA), impairing several hepatic metabolic processes leading to hyperinsulinemia .On the other side, there is an increase in the secretion of different adipokines, such as interleukin IL-6 and tumor necrosis factor-α (TNF-α), which also contributes to the insulin-resistant state .\n\nSo, RF technology deployed by Vanquish uses oscillating electrical current forcing collisions between charged molecules and ions, which are then transformed into heat. Since fat biophysical characteristics behave like an insulator capable of polarization, it absorbs the high RF-related heat release from the RF applicator driving specific fat necrosis and consequent lipolysis. Patients lay underneath the device while the focused-field radiofrequency heats up the underlying .', 'detailedDescription': 'The eligible participants will be divided into two equal groups included fifty two post-menopausal women. They will be selected randomly from El kalil Ebrahem hospital in Hadaek El Maadi.\n\nEach group will be twenty six women. Group (A) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits. This group will receive 30 minutes on the abdominal area by radiofrequency, twice per week. The treatment procedure consists of placing the emitting panel over abdomen and flanks close to the skin using a spacer which standardizes distance between the panel and the body surface.\n\nOnce it is in supine position, with a pillow under their heads and with their knees in flexion. Initially, the abdominal region of each participant was divided into two equal parts- right and left-with the line Alba as reference.\n\nGroup (B) (control group) will receive regular diet habits only.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '48 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • All participants post-menopausal from at least 3 years.\n\n * All participants' ages will be ranged from 48-60 years old.\n * All participants BMI will exceed 30 kg/m2.\n * All participants waist hip ratio will be equal or more than 0, 89.\n\nExclusion Criteria:\n\n* • Surgical liposuction within the last 12 months.\n\n * Untreated hypo- or hyperthyroidism.\n * Uncontrolled liver, kidney or cardiovascular disease or diabetes.\n * Implanted pacemaker or metal implant.\n * History of thrombophlebitis, any hematological disease.\n * No past or present neurological and musculoskeletal disorders that will have affected health condition.\n * No smoking and drinking habits.\n * No psychological problems."}, 'identificationModule': {'nctId': 'NCT05818293', 'briefTitle': 'Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women', 'orgStudyIdInfo': {'id': '012/003806'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group -control group', 'description': 'Group (A) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits.', 'interventionNames': ['Device: radiofrquency device']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Group (B) (control group) will receive regular diet habits only.'}], 'interventions': [{'name': 'radiofrquency device', 'type': 'DEVICE', 'description': '• The radiofrequency system has been used for treatment of subcutaneous fat layers.', 'armGroupLabels': ['study group -control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19899', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shymaa M. Mohammed', 'role': 'CONTACT', 'email': 'shymaamohammed269@gmail.com', 'phone': '+201096777275'}, {'name': 'Dalia D. Awad, PHD', 'role': 'CONTACT', 'email': 'dalia82@gmail.com', 'phone': '+2012273990045'}], 'facility': 'Hadiek El Maadi center', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Shymaa M Mohammed, MSc', 'role': 'CONTACT', 'email': 'shymaamohammed269@gmail.com', 'phone': '+201096777275'}, {'name': 'Dalia D Awad, PHD', 'role': 'CONTACT', 'email': 'Dalia82@gmail.com', 'phone': '01273990045'}], 'overallOfficials': [{'name': 'Shymaa M. Mohammed, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physiotherapist', 'investigatorFullName': 'Shymaa Mohammed Abdo Mohammed', 'investigatorAffiliation': 'Cairo University'}}}}