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

NCT07119892 | Completed DMC

• 1 other identifier: SU.REC.2025(46H)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• MDA (mmol/L)

  Baseline and Week 12

• CD (mmol/L)

  Baseline and Week 12

• GSH (mmol/gHb)

  Baseline and Week 12

• GPx (units/gHb)

  Baseline and Week 12

• SOD (units/mL)

  Baseline and Week 12

Study Arms (2)

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.

Behavioral: Lifestyle Modification (Exercise + Diet)

Standard Care Group

NO INTERVENTION

Participants received routine nephrology care without structured lifestyle changes.

Interventions

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.

Lifestyle Modification Group (Intervention)

Eligibility Criteria

• Age: 36 Years - 58 Years
• Gender Eligibility Details: 36 Years to 58 Years (Adult)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinai University: lead

Study Sites (1)

Manshyet El-Bakry Hospital

Cairo, 44511, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation; Renal Insufficiency, Chronic

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: March 1, 2025
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

EG (1)