Effect of Cryolipolysis on Insulin Resistance

Launched by CAIRO UNIVERSITY · Jan 23, 2024

Nctid: NCT06223490

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003924", "term"=>"Diabetes Mellitus, Type 2"}, {"id"=>"D000007333", "term"=>"Insulin Resistance"}], "ancestors"=>[{"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000006946", "term"=>"Hyperinsulinism"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "relevance"=>"LOW"}, {"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Type 2 Diabetes Mellitus", "relevance"=>"HIGH"}, {"id"=>"M10370", "name"=>"Insulin Resistance", "asFound"=>"Insulin Resistance", "relevance"=>"HIGH"}, {"id"=>"M28427", "name"=>"Obesity, Abdominal", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M9997", "name"=>"Hyperinsulinism", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M10365", "name"=>"Insulin", "relevance"=>"LOW"}, {"id"=>"M173166", "name"=>"Insulin, Globin Zinc", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hypoglycemic Agents", "abbrev"=>"Hypo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-11-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-01-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-06", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-01-20", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Skin fold thickness and estimation of total body fat", "timeFrame"=>"3 months", "description"=>"Estimation of body fat for all cases and is done by measuring these parameters :\n\nweight in kilograms, height in meters as weight and height will be combined to report BMI in kg/m\\^2."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["TII DM", "Obese Females", "Cryolipolysis"], "conditions"=>["Type 2 Diabetes Mellitus in Obese", "Cryotherapy Effect"]}, "descriptionModule"=>{"briefSummary"=>"Diabetes mellitus (DM) is a complex chronic illness associated with a state of high blood glucose level, or hyperglycemia, occurring from deficiencies in insulin secretion, action, or both.\n\nDiabetes mellitus is the name given to a wide spectrum group of disorders characterized by raised plasma glucose.Type 1 diabetes is characterized by an absolute insulin deficiency due to autoimmune destruction of insulin producing beta cells in the pancreas.\n\nmost adults with diabetes have type 2, characterized by a relative insulin secretory defect, and target tissue resistance to the effects of insulin.", "detailedDescription"=>"Diabetes is one of the most important health problems and chronic metabolic diseases requiring critical care.The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014.\n\nType 2 diabetes mellitus is a common and increasingly prevalent disease and is thus a major public health concern worldwide. The International Diabetes Federation estimates that there are approximately 387 million people diagnosed with diabetes across the globe.\n\nThe clinical diagnosis of diabetes is reliant on either one of the four plasma glucose (PG) criteria: elevated (i) fasting plasma glucose (FPG) (\\>126 mg/dL), (ii) 2 h PG during a 75-g oral glucose tolerance test (OGTT) (\\>200 mg/dL), (iii) random PG (\\>200 mg/dL) with classic signs and symptoms of hyperglycemia, or (iv) hemoglobin A1C level \\>6.5%.\n\nThe principal tissues affected by insulin resistance are liver, muscle and fat. In the liver this impaired insulin related inhibition of hepatic gluconeogenesis results in increased hepatic glucose output, exacerbating hyperglycemia.\n\nIn muscle, reduced transport of carbohydrates into muscle combined with lipid deposition in muscle cells leads toimpaired exercise ability and lowered threshold for tiredness with exercise. In fat tissue, there is impaired insulin-mediated inhibition of hormone dependent lipase, with breakdown of lipids to free fatty acids and glycerol, contributing to the dyslipidemia. With the rise in diabetes prevalence, researchers have increasingly investigated treatments intended to improve health and quality of life. People are much more likely to achieve metabolic control when they adhere to recommended diets, medications and exercise behaviors.\n\nCryolipolysis (CoolSculpting, Zeltiq, Pleasanton, CA) is a novel method of selective removal of fat with cooling. This technique is basedon the concept that fat cells are more sensitive to cold than the surrounding tissue. Prior studies and observations have demonstrated that cold exposure can induce selective damage to the subcutaneous fat via induction of panniculitis, resulting in reduction in the superficial fat layer of the skin"}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"45 years", "minimumAge"=>"35 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with incidence of diabetes 5 years ago.\n* Patient fasting glucose level is more than 140 mg/dL.\n* Age will be ranged from 35 to 45 years\n* Body mass index between 25 and 30.\n* All patients are medically controlled\n* All patients have the same medical care.\n* All patients will receive a good explanation of treatment procedures.\n\nExclusion Criteria:\n\n* Patients dependent on insulin.\n* Renal failure.\n* Myocardial infractions.\n* Cardiovascular problems.\n* Neurological disorders.\n* Patients with orthopedic problems (e.g mal or incomplete union of fracture, ankle sprains.\n* Abdominal hernia\n* Skin disease\n* Unstable cases"}, "identificationModule"=>{"nctId"=>"NCT06223490", "briefTitle"=>"Effect of Cryolipolysis on Insulin Resistance", "organization"=>{"class"=>"OTHER", "fullName"=>"Cairo University"}, "officialTitle"=>"Effect of Cryolipolysis on Insulin Resistance in Type 2 Diabetic Females With Abdominal Obesity", "orgStudyIdInfo"=>{"id"=>"Noura Fahmy"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Cryolipolysis Group", "description"=>"About 30 obese females with type 2 diabetes and will face cryolypolysis in addition to exercise therapy treatment", "interventionNames"=>["Procedure: Cryolipolysis"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Group of Exercise", "description"=>"About 30 obese females with type 2 diabetes and will face exercise therapy treatment only.", "interventionNames"=>["Procedure: Cryolipolysis"]}], "interventions"=>[{"name"=>"Cryolipolysis", "type"=>"PROCEDURE", "otherNames"=>["Exercise therapy"], "description"=>"To investigate the Effect of Cryolipolysis On insulin resistance and In adult type 2 female patients.", "armGroupLabels"=>["Cryolipolysis Group", "Group of Exercise"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Cairo", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Mona AbdelWahab, Lecturer", "role"=>"CONTACT", "email"=>"monaahmed198748@yahoo.com", "phone"=>"+201117203904"}, {"name"=>"Maha Saber, Professor", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Faculty of Physical Therapy, Cairo University", "geoPoint"=>{"lat"=>30.06263, "lon"=>31.24967}}], "centralContacts"=>[{"name"=>"NOURA RAMADAN, MSC", "role"=>"CONTACT", "email"=>"drnourramadaan@gmail.com", "phone"=>"+201158577826"}], "overallOfficials"=>[{"name"=>"Akram Abd El Aziz, Assist.Prof", "role"=>"STUDY_CHAIR", "affiliation"=>"Cairo University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Cairo University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Resident of Physical therapy", "investigatorFullName"=>"Noura Ramadan Fahmy", "investigatorAffiliation"=>"Cairo University"}}}}