Inflammatory Cytokines and Oxidative Stress Biomarkers in Diabetic Chronic Kidney Disease Patients (intervention)

June 14, 2026 updated by: Mona Mohamed Abdelkhalek, Badr University

Inflammatory Cytokines and Oxidative Stress Biomarkers Response to Life Style Modification in Diabetic Chronic Kidney Disease Patients

This research intends to analyze how a 12-week adjustment in lifestyle influences inflammatory cytokines and oxidative stress indicators in overweight individuals diagnosed with type 2 diabetes and moderate CKD

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

: 60 patients, mostly sedentary, aged 36-58 years, were diagnosed with stages 3 and 4 chronic kidney disease (eGFR 25 to 60 ml/min/1.73 m²) with concomitant type 2 diabetes and indicated body mass indexes (BMI) between 30 to 35 kg/m². The subjects were randomly assigned to two unique groups: Intervention group (Group A): Participants completed supervised aerobic treadmill exercises while sticking to a calorie-limited diet (1200 kcal/day) throughout a 12-week period. Control group (Group B): Participants received standard nephrology care without any alterations in lifestyle. In the initial phases, there was a detailed analysis of biomarkers which was later confirmed in a review conducted at the 12-week mark focusing on TNF-α, IL-6, sCRP, CD, MDA, GSH, GPx, and SOD.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mona Mohamed Abdelkhalek, assistance professor
  • Phone Number: 00201024056108
  • Email: 3m.sons@gmail.com

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Mona Mohamed Abdelkhalek
        • Contact:
          • Mona Mohamed Abdelkhalek, assistance prof
          • Phone Number: 002021024056108
          • Email: 3m.sons@gmail.com
        • Contact:
          • Mona mohamed Abdekhalek, assistance prof
          • Phone Number: 01024056108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • sedentary lifestyle for at least three months prior to enrollment
  • body mass index (BMI) of 30-35 kg/m².

Exclusion Criteria:

  • using tobacco
  • heart failure
  • coronary arteries
  • severe heart valve problems
  • pregnant
  • liver inflammation
  • kidney transplant
  • physical injuries restricting them from exercising
  • utilization of anti-inflammatory medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (Group A)
Participants completed supervised aerobic treadmill exercises while sticking to a calorie-limited diet (1200 kcal/day) throughout a 12-week period.
Other: aerobic treadmill exercises
diet (1200 kcal/day)
Other Names:
  • a calorie-limited diet (1200 kcal/day)
No Intervention: group (B)
Participants received standard nephrology care without any alterations in lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDA
Time Frame: at baseline and after 12 WEEKS
malondialdehyde
at baseline and after 12 WEEKS
GSH
Time Frame: at baseline and after 12 WEEKS
Glutathione
at baseline and after 12 WEEKS
GPx
Time Frame: at baseline and after 12 WEEKS
Glutathione peroxidase
at baseline and after 12 WEEKS
SOD
Time Frame: at baseline and after 12 WEEKS
Superoxide dismutase
at baseline and after 12 WEEKS
IL-6
Time Frame: at baseline and after 12 WEEKS
Interleukin-6
at baseline and after 12 WEEKS
TNF-α
Time Frame: at baseline and after 12 WEEKS
tumor necrosis factor alpha
at baseline and after 12 WEEKS
CRP
Time Frame: at baseline and after 12 WEEKS
C-reactive protein
at baseline and after 12 WEEKS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: at baseline and after 12 WEEKS
Body mass index
at baseline and after 12 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Investigators

  • Principal Investigator: Mona Mohamed Abdelkhalek, Badr University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2026

Primary Completion (Estimated)

September 7, 2026

Study Completion (Estimated)

September 7, 2026

Study Registration Dates

First Submitted

June 14, 2026

First Submitted That Met QC Criteria

June 14, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 14, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diabetic kidney disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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