NCT07119892Completed
Lifestyle Intervention and Its Effects on Inflammatory Cytokines and Oxidative Stress Markers in Diabetic Chronic Kidney Disease Patients: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 17 Aug 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 6 Aug 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 25 Jun 2025
- Lead sponsor
- Sinai University
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT07119892
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 1 Mar 2025 to the primary completion date, 25 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use anti-inflammatory medications regularly
- Have received a kidney transplant
Other illness
- Have congestive heart failure (CHF) or coronary artery disease (CAD)
- Have moderate to severe valvular heart disease
- Have respiratory failure or chronic pulmonary disease
Lab values
- Have active liver disease (ALT \> 3× upper normal limit)
Other
- Participants will be excluded if they:
- Have orthopedic limitations preventing exercise participation
- Are currently pregnant or lactating
- Are smokers (current) Have participated in a lifestyle intervention trial within the last 6 months
Who the study is looking for
- 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
Age in the registry: 36 years to 58 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Manshyet El-Bakry Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.