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NCT Number: NCT07657286

Inflammatory Cytokines and Oxidative Stress Biomarkers 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

Recruiting

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Key information

Conditions

Chronic Kidney Disease Body Weight Body Weight Changes Chronic Disease Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases Weight Loss

Age range

36 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mona Mohamed Abdelkhalek

Cairo, Egypt

Location status: Recruiting

Location contact

Mona Mohamed Abdelkhalek, assistance prof

CONTACT

[email protected]

002021024056108

Mona mohamed Abdekhalek, assistance prof

CONTACT

01024056108

About this study

: 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

aerobic treadmill exercises

Other

diet (1200 kcal/day)

Other names: a calorie-limited diet (1200 kcal/day)

Primary outcomes

  1. MDA

    Time frame: at baseline and after 12 WEEKS

    malondialdehyde

  2. GSH

    Time frame: at baseline and after 12 WEEKS

    Glutathione

  3. GPx

    Time frame: at baseline and after 12 WEEKS

    Glutathione peroxidase

  4. SOD

    Time frame: at baseline and after 12 WEEKS

    Superoxide dismutase

  5. IL-6

    Time frame: at baseline and after 12 WEEKS

    Interleukin-6

  6. TNF-α

    Time frame: at baseline and after 12 WEEKS

    tumor necrosis factor alpha

  7. CRP

    Time frame: at baseline and after 12 WEEKS

    C-reactive protein

Secondary outcomes

  1. BMI

    Time frame: at baseline and after 12 WEEKS

    Body mass index

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Mohamed Abdelkhalek, assistance professor

CONTACT

[email protected]

00201024056108

Mona Mohamed Abdelkhalek, assistance professor

CONTACT

[email protected]

00201024056108

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Official study title

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

Acronym: intervention

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

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.

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