Chronic Kidney Disease, Inflammation, Chronic Low-Grade, Stage 3 Chronic Kidney Disease, Stage 4 Chronic Kidney Disease, Type 2 Diabetes Mellitus
Conditions
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.
Interventions
BEHAVIORALLifestyle 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.
Sponsors
Sinai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
single Outcomes Assessor
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
36 Years to 58 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| GPx (units/gHb) | Baseline and Week 12 | Glutathione peroxidase enzyme activity |
| MDA (mmol/L) | Baseline and Week 12 | Malondialdehyde levels (oxidative stress marker) |
| BMI (kg/m²) | Baseline and Week 12 | Body mass index |
| SOD (units/mL) | Baseline and Week 12 | Superoxide dismutase activity |
| CD (mmol/L) | Baseline and Week 12 | Conjugated dienes levels |
| GSH (mmol/gHb) | Baseline and Week 12 | Reduced glutathione level |
Countries
Egypt
Outcome results
None listed