Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-02 @ 3:41 AM
Study NCT ID:
NCT06772857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2024-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'Study group A (20 patients):will receive aerobic exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.\n\nStudy group B (20 patients): will receive resistance exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.\n\nControl group C (20 patients): will receive medical and diet regimen only for six weeks. The patients will be instructed not to change their physical activity during the study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-11', 'studyFirstSubmitDate': '2024-12-29', 'studyFirstSubmitQcDate': '2025-01-11', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Insulin Resistance Between Different Exercise Modes in Obese Patients', 'timeFrame': '3months', 'description': 'The change in insulin resistance will be assessed using the HOMA-IR index in obese patients after different exercise interventions (aerobic vs resistance) compared to baseline. The HOMA-IR index will be calculated based on fasting blood glucose and fasting insulin levels, which are widely accepted measures of insulin resistance.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Sensitivity/Resistance']}, 'descriptionModule': {'briefSummary': 'The purpose of study is to compare the effect of different exercise modes on insulin resistance and body composition in obese patients.', 'detailedDescription': 'The global epidemic of obesity becomes a major healthy, social, and economical burden.Indeed, it has been well established that obesity directly increases cardio metabolic risk by altering the insulin sensibility. Moreover, obesity causes additional health problems as it is closely associated with the development and progression of coronary heart disease.\n\nAccording to the World Health Organization (WHO), Egypt ranks 18th with the highest prevalence of obesity worldwide.( Global Obesity Levels,2020) Deaths attributable to non-communicable diseases represent about 71% of the total mortality burden .(World Health Organization,2021) Lack of exercise and sedentary behaviour (prolonged sitting) are major risk factors for insulin resistance The prevalence of obesity has increased in adults in Egypt to reach about 40% according to 100million health survey (2019) compared to the 36% estimate of 2017 STEPwise survey .\n\nThis review presents established knowledge on the effects of physical activity (PA) on whole-body insulin sensitivity (SI) and body composition .\n\n1. Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.\n2. Their body mass index will be ranged from 30 to 34.9 kg/m2.\n3. They have insulin resistance assessed by the homeostasis model assessment for insulin resistance (HOMAIR) Levels above 1.9\n4. Their blood glucose level will be ranged from 100 to 125 mg/dL (5.6-6.9 mmol/l)\n5. They will receive the same medical and diet regimen in addition to instructions not to change their physical activity during the study.\n\nStudy group A (20 patients):will receive aerobic exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.\n\nStudy group B (20 patients): will receive resistance exercise training in addition to medical and diet regimen. This mode of exercise training will be applied 3 times/week for six weeks.\n\nControl group C (20 patients): will receive medical and diet regimen only for six weeks. The patients will be instructed not to change their physical activity during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sixty obese prediabetic patients from both sexes with ages ranging from 30 to 40 years old.\n* Body mass index (BMI) ranging from 30 to 34.9 kg/m².\n* Insulin resistance as assessed by the homeostasis model assessment for insulin resistance (HOMA-IR) levels above 1.9.\n* Blood glucose levels ranging from 100 to 125 mg/dL (5.6-6.9 mmol/L).\n* Patients will receive the same medical and diet regimen, with instructions not to change their physical activity during the study.\n* HbA1c levels between 6.0% and 6.5%, indicating high risk for diabetes and possible consideration for prevention interventions.\n\nExclusion Criteria:\n\n* Uncontrolled diabetes.\n* Uncontrolled hypertension.\n* Cardiovascular disease.\n* Respiratory disease.\n* Hepatic disease.\n* Severe life-limiting illness (e.g., cancer).\n* Use of weight loss medications.\n* Orthopedic or neurological disorders that limit exercise participation.\n* Endocrine disorders.\n* Kidney disease.'}, 'identificationModule': {'nctId': 'NCT06772857', 'briefTitle': 'Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Aerobic Versus Resistance Exercises on Insulin Sensitivity in Obese Patients', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Aerobic Exercise + Medical and Diet Regimen', 'description': 'Study group A (20 patients) will receive aerobic exercise training in addition to a medical and diet regimen. Aerobic exercise training will be applied 3 times per week for 6 weeks. This exercise will include activities such as walking, cycling, or swimming to improve cardiovascular fitness and insulin sensitivity.', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Resistance Exercise + Medical and Diet Regimen', 'description': 'Study group B (20 patients) will receive resistance exercise training along with a medical and diet regimen. Resistance exercise training will be applied 3 times per week for 6 weeks, focusing on strength-building exercises to improve muscle mass and insulin sensitivity.', 'interventionNames': ['Drug: Metformin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C: Medical and Diet Regimen Only', 'description': 'Control group C (20 patients) will receive only a medical and diet regimen for 6 weeks. Patients in this group will be instructed not to change their physical activity during the study period.', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage', 'Glucophage XR', 'Riomet'], 'description': 'Metformin is a drug used to manage blood glucose levels. It improves insulin sensitivity and reduces glucose production in the liver. This regimen will be provided to all study groups (A, B, and C) in combination with the respective interventions described for each group. Participants are instructed not to change their physical activity during the study.', 'armGroupLabels': ['Group A: Aerobic Exercise + Medical and Diet Regimen', 'Group B: Resistance Exercise + Medical and Diet Regimen', 'Group C: Medical and Diet Regimen Only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'El-sayed Felaya', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Respiratory Disorder and Geriatrics Faculty of Physical Therapy Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Police Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer at Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University', 'investigatorFullName': 'El-Sayed Essam', 'investigatorAffiliation': 'Cairo University'}}}}