Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 10:06 PM
Study NCT ID:
NCT07119892
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in Diabetic Chronic Kidney Disease Patients: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'single Outcomes Assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TNF-α (pg/mL)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change in tumor necrosis factor-alpha'}, {'measure': 'sCRP (mg/L)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change in serum C-reactive protein levels'}, {'measure': 'IL-6 (pg/mL)', 'timeFrame': 'Baseline and Week 12', 'description': 'Change in interleukin-6 levels'}], 'secondaryOutcomes': [{'measure': 'MDA (mmol/L)', 'timeFrame': 'Baseline and Week 12', 'description': 'Malondialdehyde levels (oxidative stress marker)'}, {'measure': 'CD (mmol/L)', 'timeFrame': 'Baseline and Week 12', 'description': 'Conjugated dienes levels'}, {'measure': 'GSH (mmol/gHb)', 'timeFrame': 'Baseline and Week 12', 'description': 'Reduced glutathione level'}, {'measure': 'GPx (units/gHb)', 'timeFrame': 'Baseline and Week 12', 'description': 'Glutathione peroxidase enzyme activity'}, {'measure': 'SOD (units/mL)', 'timeFrame': 'Baseline and Week 12', 'description': 'Superoxide dismutase activity'}, {'measure': 'BMI (kg/m²)', 'timeFrame': 'Baseline and Week 12', 'description': 'Body mass index'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Inflammation, Chronic Low-Grade', 'Chronic Kidney Disease', 'Stage 3 Chronic Kidney Disease', 'Stage 4 Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigated the effects of a 12-week structured lifestyle intervention-including supervised aerobic exercise and a calorie-restricted diet-on inflammatory cytokines and oxidative stress biomarkers in overweight adults with type 2 diabetes mellitus (T2DM) and moderate chronic kidney disease (CKD stages 3-4). A total of 60 sedentary participants aged 36-58 years were randomly assigned to either the intervention group or the control group. The primary outcomes included changes in TNF-α, IL-6, and sCRP levels. Secondary outcomes assessed oxidative stress markers (MDA, CD) and antioxidant enzymes (GSH, SOD, GPx).', 'detailedDescription': 'Diabetic CKD is characterized by chronic low-grade inflammation and heightened oxidative stress, both of which contribute significantly to cardiovascular morbidity and kidney function decline. This study evaluated whether a 12-week structured lifestyle intervention could improve systemic inflammatory and oxidative profiles in overweight adults with T2DM and CKD stages 3-4. Participants in the intervention group underwent supervised aerobic exercise (5 sessions/week) and received individualized dietary counseling with a 1,200 kcal/day Mediterranean-style diet. The control group received standard nephrology care without lifestyle modification. Outcomes were measured pre- and post-intervention and included pro-inflammatory markers (TNF-α, IL-6, sCRP), lipid peroxidation markers (MDA, CD), and antioxidant defenses (GSH, SOD, GPx). The intervention group demonstrated statistically significant improvements in all biomarker categories compared to controls. The study supports the integration of structured lifestyle interventions into standard care for diabetic CKD patients to improve redox balance and reduce inflammatory burden.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '58 Years', 'minimumAge': '36 Years', 'genderBased': True, 'genderDescription': '36 Years to 58 Years (Adult)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants must meet all of the following:\n\n* Diagnosed with Type 2 Diabetes Mellitus (T2DM)\n* Diagnosed with moderate chronic kidney disease (CKD Stage 3 or 4), with eGFR 25-60 mL/min/1.73 m²\n* Age between 36 and 58 years\n* BMI between 30-35 kg/m² (classified as obese)\n* Sedentary lifestyle, defined as \\<30 minutes of physical activity per week over the past 6 months\n* Stable medication regimen for at least 3 months\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Participants will be excluded if they:\n* Use anti-inflammatory medications regularly\n* Have congestive heart failure (CHF) or coronary artery disease (CAD)\n* Have moderate to severe valvular heart disease\n* Have active liver disease (ALT \\> 3× upper normal limit)\n* Have orthopedic limitations preventing exercise participation\n* Are currently pregnant or lactating\n* Have received a kidney transplant\n* Have respiratory failure or chronic pulmonary disease\n* Are smokers (current) Have participated in a lifestyle intervention trial within the last 6 months'}, 'identificationModule': {'nctId': 'NCT07119892', 'acronym': 'Lifestyle Inte', 'briefTitle': 'Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in Diabetic Chronic Kidney Disease Patients: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sinai University'}, 'officialTitle': 'Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in Diabetic Chronic Kidney Disease Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SU.REC.2025(46H)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle Modification Group (Intervention)', 'description': 'Participants engaged in a 12-week supervised aerobic exercise program (5x/week) at 70% of max HR, plus a calorie-restricted Mediterranean-style diet (1,200 kcal/day). Weekly dietitian counseling included Ramadan adjustments.', 'interventionNames': ['Behavioral: Lifestyle Modification (Exercise + Diet)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care Group', 'description': 'Participants received routine nephrology care without structured lifestyle changes.'}], 'interventions': [{'name': 'Lifestyle Modification (Exercise + Diet)', 'type': 'BEHAVIORAL', 'description': 'Participants received a 12-week supervised aerobic exercise program (5 sessions per week at 70% of age-predicted maximum heart rate) and dietary counseling with a calorie-restricted Mediterranean-style diet of 1,200 kcal/day. The intervention was culturally adapted, including modifications for Ramadan.', 'armGroupLabels': ['Lifestyle Modification Group (Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44511', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Manshyet El-Bakry Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Amany Gomaa Atiaa', 'investigatorAffiliation': 'Sinai University'}}}}