Clinical trial Recruiting at 1 site Interventional Ages 36 to 58

Weight-loss with exercise and diet in adults with type 2 diabetes and CKD

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

Run by Badr University · NCT07657286 · Data updated 2026-11-12

This study tests whether a 12-week supervised aerobic exercise program plus a calorie‑restricted diet can change inflammatory and oxidative stress biomarkers in overweight adults with type 2 diabetes and moderate chronic kidney disease.

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Quick facts

Study typeInterventional
Ages36 Years to 58 Years
SexAll
Enrollment60 (estimated)
SponsorBadr University
Academic / other
Locations1 site (Cairo)
StatusRecruiting
StartedJune 7, 2026
Main results expectedSeptember 7, 2026
Study endsSeptember 7, 2026
Registry record updatedJune 18, 2026
Trial IDNCT07657286 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are sedentary adults aged 36–58 with type 2 diabetes and stage 3–4 CKD, BMI 30–35 kg/m², not on tobacco or anti-inflammatory meds, and able to participate in a supervised exercise program.

Probably not a fit

Patients who do not respond to lifestyle changes, have uncontrolled cardiovascular risk, or cannot safely participate in exercise may not experience biomarker improvements.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls 60 sedentary adults aged 36–58 with stage 3–4 CKD and type 2 diabetes, BMI 30–35 kg/m². Participants are randomized to receive a 12-week program of supervised aerobic treadmill training plus a 1200 kcal/day diet or standard nephrology care without lifestyle changes. Biomarkers such as TNF-α, IL-6, sCRP, CD, MDA, GSH, GPx, and SOD are measured at baseline and after 12 weeks to assess the biological impact of the lifestyle intervention. The trial aims to determine if lifestyle modification can modulate inflammatory and oxidative stress pathways in this high-risk population.

Why it matters

Potential benefit: If successful, participants may experience beneficial changes in inflammation and oxidative stress markers, which could be associated with better health outcomes.

How similar studies have gone: Previous studies in related populations have shown biomarker changes with lifestyle interventions, but this specific combination in diabetes with CKD and higher BMI is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Mona Mohamed Abdelkhalek
    Cairo, Egypt
    Recruiting

Study contacts

  • Principal investigator: Mona Mohamed Abdelkhalek — Badr University
  • Study coordinator: Mona Mohamed Abdelkhalek, assistance professor
  • Email: 3m.sons@gmail.com
  • Phone: 00201024056108

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.