Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in … (NCT07119892) | Clinical Trial Compass
CompletedNot Applicable
Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in Diabetic Chronic Kidney Disease Patients: A Randomized Controlled Trial
Egypt60 participantsStarted 2025-03-01
Plain-language 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).
Who can participate
Age range
36 Years – 58 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.