Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Modification Group (Intervention) | Experimental | 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. |
|
| Standard Care Group | No Intervention | Participants received routine nephrology care without structured lifestyle changes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Modification (Exercise + Diet) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TNF-α (pg/mL) | Change in tumor necrosis factor-alpha | Baseline and Week 12 |
| sCRP (mg/L) | Change in serum C-reactive protein levels | Baseline and Week 12 |
| IL-6 (pg/mL) | Change in interleukin-6 levels | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| MDA (mmol/L) | Malondialdehyde levels (oxidative stress marker) | Baseline and Week 12 |
| CD (mmol/L) | Conjugated dienes levels | Baseline and Week 12 |
Not provided
Inclusion Criteria:
Participants must meet all of the following:
Exclusion Criteria:
36 Years to 58 Years (Adult)
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manshyet El-Bakry Hospital | Cairo | 44511 | Egypt |
Not provided
Parallel Assignment
Not provided
Not provided
single Outcomes Assessor
|
| GSH (mmol/gHb) | Reduced glutathione level | Baseline and Week 12 |
| GPx (units/gHb) | Glutathione peroxidase enzyme activity | Baseline and Week 12 |
| SOD (units/mL) | Superoxide dismutase activity | Baseline and Week 12 |
| BMI (kg/m²) | Body mass index | Baseline and Week 12 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided