Inflammatory Cytokines and Oxidative Stress Biomarkers in Diabetic Chronic Kidney Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: aerobic treadmill exercises.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease, Diabetes. Basic parameters: 36 years — 58 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Inflammatory Cytokines and Oxidative Stress Biomarkers Response to Life Style Modification in Diabetic Chronic Kidney Disease Patients
Overview
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
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.
Interventions
- Other aerobic treadmill exercises
diet (1200 kcal/day)
Primary outcome measures
- MDA [Time frame: at baseline and after 12 WEEKS]
- GSH [Time frame: at baseline and after 12 WEEKS]
- GPx [Time frame: at baseline and after 12 WEEKS]
- SOD [Time frame: at baseline and after 12 WEEKS]
- IL-6 [Time frame: at baseline and after 12 WEEKS]
- TNF-α [Time frame: at baseline and after 12 WEEKS]
- CRP [Time frame: at baseline and after 12 WEEKS]
Secondary outcome measures (1)
- BMI [Time frame: at baseline and after 12 WEEKS]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Mona Mohamed Abdelkhalek — Cairo
Identifiers
NCT: NCT07657286 · diabetic kidney disease