NCT07119892

Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in Diabetic Chronic Kidney Disease Patients: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Sinai University · Academic / Other
• Sex: All
• Age: 36 Years – 58 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus
• Inflammation, Chronic Low-Grade
• Chronic Kidney Disease
• Stage 3 Chronic Kidney Disease
• Stage 4 Chronic Kidney Disease

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle Modification (Exercise + Diet)	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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2025-08-13
• Last updated: 2025-08-17

Locations

1 site across 1 country: Egypt