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

Not Applicable

Completed

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

• Registration Number: NCT07119892
• Lead Sponsor: Sinai University

Brief 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.

Study Timeline

• Study Start: 2025-03-01
• Primary Completion: 2025-06-25
• Study Completion: 2025-06-25
• Status Verified: 2025-08
• Study First Submitted: 2025-08-06
• Study First Submitted QC: 2025-08-06
• Study First Posted: 2025-08-13
• Last Update Submitted: 2025-08-13
• Last Update Posted: 2025-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants must meet all of the following:

• Diagnosed with Type 2 Diabetes Mellitus (T2DM)
• Diagnosed with moderate chronic kidney disease (CKD Stage 3 or 4), with eGFR 25-60 mL/min/1.73 m²
• Age between 36 and 58 years
• BMI between 30-35 kg/m² (classified as obese)
• Sedentary lifestyle, defined as <30 minutes of physical activity per week over the past 6 months
• Stable medication regimen for at least 3 months
• Willing and able to provide informed consent

Exclusion Criteria

• Participants will be excluded if they:
• Use anti-inflammatory medications regularly
• Have congestive heart failure (CHF) or coronary artery disease (CAD)
• Have moderate to severe valvular heart disease
• Have active liver disease (ALT > 3× upper normal limit)
• Have orthopedic limitations preventing exercise participation
• Are currently pregnant or lactating
• Have received a kidney transplant
• Have respiratory failure or chronic pulmonary disease
• Are smokers (current) Have participated in a lifestyle intervention trial within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TNF-α (pg/mL)	Baseline and Week 12	Change in tumor necrosis factor-alpha
sCRP (mg/L)	Baseline and Week 12	Change in serum C-reactive protein levels
IL-6 (pg/mL)	Baseline and Week 12	Change in interleukin-6 levels

Secondary Outcome Measures

Name	Time	Method
SOD (units/mL)	Baseline and Week 12	Superoxide dismutase activity
GSH (mmol/gHb)	Baseline and Week 12	Reduced glutathione level
GPx (units/gHb)	Baseline and Week 12	Glutathione peroxidase enzyme activity
MDA (mmol/L)	Baseline and Week 12	Malondialdehyde levels (oxidative stress marker)
CD (mmol/L)	Baseline and Week 12	Conjugated dienes levels
BMI (kg/m²)	Baseline and Week 12	Body mass index

Trial Locations

Locations (1)

Manshyet El-Bakry Hospital; 🇪🇬 Cairo, Egypt