Skip to main content
OpenTrials
Completed

NCT Number: NCT07119892

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Chronic Disease Chronic Kidney Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Inflammation Inflammation, Chronic Low-Grade Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Stage 3 Chronic Kidney Disease Stage 4 Chronic Kidney Disease Urogenital Diseases Urologic Diseases

Age range

36 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manshyet El-Bakry Hospital

Cairo, 44511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. TNF-α (pg/mL)

    Time frame: Baseline and Week 12

    Change in tumor necrosis factor-alpha

  2. sCRP (mg/L)

    Time frame: Baseline and Week 12

    Change in serum C-reactive protein levels

  3. IL-6 (pg/mL)

    Time frame: Baseline and Week 12

    Change in interleukin-6 levels

Secondary outcomes

  1. MDA (mmol/L)

    Time frame: Baseline and Week 12

    Malondialdehyde levels (oxidative stress marker)

  2. CD (mmol/L)

    Time frame: Baseline and Week 12

    Conjugated dienes levels

  3. GSH (mmol/gHb)

    Time frame: Baseline and Week 12

    Reduced glutathione level

  4. GPx (units/gHb)

    Time frame: Baseline and Week 12

    Glutathione peroxidase enzyme activity

  5. SOD (units/mL)

    Time frame: Baseline and Week 12

    Superoxide dismutase activity

  6. BMI (kg/m²)

    Time frame: Baseline and Week 12

    Body mass index

Sponsors and collaborators

Lead sponsor

Sinai University

Other

Registry information

Acronym: Lifestyle Inte

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.