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

NCT ID: NCT07119892

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-06-25

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lifestyle Modification Group (Intervention)

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.

Group Type: EXPERIMENTAL

Lifestyle Modification (Exercise + Diet)

Intervention Type: 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.

Standard Care Group

Participants received routine nephrology care without structured lifestyle changes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 36 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinai University

OTHER

Sponsor Role: lead

Responsible Party

Amany Gomaa Atiaa

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Manshyet El-Bakry Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

SU.REC.2025(46H)

Identifier Type: -

Identifier Source: org_study_id