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

Sinai University

Status: Completed

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

Treatments: Behavioral: Lifestyle Modification (Exercise + Diet)

Study type: Interventional

Funder types: Other

Identifiers

NCT07119892

SU.REC.2025(46H)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 36 to 58 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Lifestyle Modification Group (Intervention)

Experimental group

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.

Treatment:

Behavioral: Lifestyle Modification (Exercise + Diet)

Standard Care Group

No Intervention group

Description:

Participants received routine nephrology care without structured lifestyle changes.