Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
Study NCT ID:
NCT06246435
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2024-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Supervised Aerobic Training on Dyslipidemia Among Diabetic Older Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'For all participants, standardized physical examination and collection of serum samples were performed at week 0 (before the onset of the training program), 3 months, and after a 6-month program of moderate aerobic training'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of body weight, and height as anthropometric measurements', 'timeFrame': '6 month', 'description': "In this test we are trying to explorer the effects of exercise training on anthropometric parameter's. Thus, weight, and height, and standardized measurements of weight and height were taken in light clothing without shoes for all patient groups"}, {'measure': 'Assessment of body mass index ( BMI in kg/m^2)as anthropometric measurements', 'timeFrame': '6 month', 'description': 'In this test, BMI from body weight and height measurements for each participant were estimated before and after exercise training interventions by using a bioelectrical impedance analysis (BIA) based body composition analyzer (TBF 105, Tanita Corporation, Tokyo, Japan)'}], 'secondaryOutcomes': [{'measure': 'Analysis of diabetic control parameters', 'timeFrame': '6 month', 'description': 'the levels of HbA1c and insulin of the participants were estimated before and after the exercise test.'}, {'measure': 'estimation of lipid profile', 'timeFrame': '6 month', 'description': 'lipid profile like total cholesterol, triglycerides, HDL-Cholesterol, and LDL-Cholesterol were estimated in the serum of each participant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '39385223', 'type': 'DERIVED', 'citation': 'Alghadir AH, Gabr SA, Iqbal A. The effects of supervised aerobic training on dyslipidaemia among diabetic older patients. BMC Endocr Disord. 2024 Oct 9;24(1):212. doi: 10.1186/s12902-024-01745-8.'}]}, 'descriptionModule': {'briefSummary': 'In this study, we are trying to explore the potential effects of moderate aerobic exercise for six months on the severity values of blood sugar, HbA1c, insulin, lipid profile, and highly sensitive CRP (hs-CRP) in a total of 50 subjects diagnosed with diabetes for more than five years with an age range of 30-70 years.', 'detailedDescription': 'This study explored the influence of 6 months of moderate-intensity supervised aerobic training on diabetic control parameters, serum lipid profile, hs-CRP, and variable-related correlations in prediabetic and type 2 diabetic patients (T2MD). The patients were classified into two groups: the prediabetes group (HbA1c ≤ 6.5, n = 25) and the T2MD group (HbA1c ≥ 6.5, n = 25). The values of blood sugar, HbA1c, insulin, lipid profile, and highly sensitive CRP (hs-CRP) were measured in all subjects by using colorimetric and immunoassay techniques respectively at baseline and postintervention of moderate aerobic exercise for six months. Participants performed the exercise test three times per week for 6 months. The training set comprised of a warming phase by stretching exercises and walking for 5 to 10 minutes, the participants were allowed to reach their precalculated training heart rate (THR) in bout form with a total time of 45 to 60 minutes performed as circuit training using a treadmill, bicycle, and stair master. All patient groups were subjected to estimate diabetic control parameters such as FBS, FI, HbA1c, serum lipid profile, hs-CRP, and BMI as anthropometric changes before and after moderate aerobic exercise training for six month'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Fifty participants aged 30-70 years diagnosed with type 2 diabetes (DM2) for more than 5 years according to the American Diabetes Association criteria were invited to this study. Based on ADA criteria, the subjects were classified according to the level of glycated hemoglobin (HbA1c) into two groups; the prediabetic group (HbA1c ≤ 6.5, n=25) and the diabetic group (HbA1c ≥ 6.5, n=25).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiagnosed with type 2 diabetes (DM2) for more than 5 years according to the American Diabetes Association criteria\n\nExclusion Criteria:\n\n* Patients with a history of smoking, abnormal alcohol intake, anemia, overt complications of diabetes like nephropathy, neuropathy, retinopathy, and other heart complications, and are suffering from viral infections, chronic liver disease, hypothyroidism, and drugs (diuretics; oral contraceptives) were excluded from this study'}, 'identificationModule': {'nctId': 'NCT06246435', 'acronym': 'T2MD', 'briefTitle': 'The Effects of Supervised Aerobic Training on Dyslipidemia Among Diabetic Older Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'The Effects of Supervised Aerobic Training on Dyslipidemia Among Diabetic Older Patients', 'orgStudyIdInfo': {'id': 'RRC-2014-010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prediabetic group', 'description': 'The prediabetic group (HbA1c ≤ 6.5, n = 25)', 'interventionNames': ['Other: moderate aerobic exercise']}, {'label': 'T2MD group', 'description': '(HbA1c ≥ 6.5, n = 25).', 'interventionNames': ['Other: moderate aerobic exercise']}], 'interventions': [{'name': 'moderate aerobic exercise', 'type': 'OTHER', 'armGroupLabels': ['Prediabetic group', 'T2MD group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical investigator', 'investigatorFullName': 'Sami Gabr', 'investigatorAffiliation': 'King Saud University'}}}}