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Biomarkers, Abdominal Muscle, and Frailty in CKD

The Association of Total Oxidant/Antioxidant Capacity and MCP-1 Markers With Abdominal Muscle Thickness and Frailty in Patients With Stage 3-5 Chronic Kidney Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07854275
Enrollment
88
Registered
2026-10-02
Start date
2025-01-15
Completion date
2026-08-01
Last updated
2026-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Abdominal Muscles/Ultrasonography, Frailty

Keywords

abdominal muscle, chronic kidney disease, monocyte chemoattractant protein-1, total antioxidant status, total oxidant status

Brief summary

In chronic kidney disease (CKD), inflammation and oxidative stress are important processes that may be associated with the development of muscle loss and frailty. The aim of this study is to investigate the relationships between serum MCP-1, total antioxidant status (TAS), and total oxidant status (TOS)-markers of inflammation and oxidative stress-and abdominal muscle thickness and frailty, as assessed by ultrasound, in stage 3-5 CKD patients not receiving dialysis. In addition, the study aims to assess participants' physical performance, kinesiophobia, and quality of life and to examine these characteristics according to CKD stages.

Detailed description

Chronic kidney disease (CKD) is a chronic condition associated not only with a decline in renal function but also with systemic effects such as inflammation, oxidative stress, muscle loss, and impaired physical function. It is hypothesized that the chronic inflammation and oxidative stress developing during the course of the disease contribute to alterations in skeletal muscle structure and function. However, data regarding the relationship of these processes with abdominal muscles in patients with advanced-stage CKD who are not undergoing dialysis are limited. This cross-sectional study aims to evaluate the associations between inflammatory and oxidative stress markers and abdominal muscle thickness and frailty in patients with stage 3-5 CKD not receiving dialysis. Serum monocyte chemoattractant protein-1 (MCP-1) is used as an inflammatory marker, while total antioxidant status (TAS), total oxidant status (TOS), and the oxidative stress index (OSI)-calculated from these values-are used to assess oxidative/antioxidative status. To assess abdominal muscles, the thicknesses of the rectus abdominis, external oblique, internal oblique, and transversus abdominis muscles are measured via ultrasonography. Frailty is assessed using the FRAIL scale and the Clinical Frailty Scale. The study also aims to examine the clinical and functional characteristics across different stages of CKD by evaluating participants' physical performance, kinesiophobia, and kidney disease-specific quality of life. This study aims to simultaneously evaluate the associations of inflammation and oxidative stress markers with abdominal muscle thickness and frailty in the same patient group, and to conduct a more comprehensive examination of muscle and functional impairment in pre-dialysis patients with stage 3-5 CKD.

Interventions

total antioxidant status

total oxidant status

OTHERmonocyte chemotactic protein-1

monocyte chemotactic protein-1

OTHERultrasonography muscle

abdominal muscles

frailty

OTHERtampa scale

kinesiophobia

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* the ages of 18 and 70 * have been diagnosed with stage 3, 4, or 5 chronic kidney disease (CKD) for at least 6 months * have been receiving stable medical treatment for the past 6 months * be in a clinically stable condition * have no cognitive impairment * be literate; and have no vision or hearing problems that would prevent the administration of the scales

Exclusion criteria

* Patients undergoing dialysis * those with acute infection * malignancy * uncontrolled hypertension * severe heart failure * a history of neurological disease (stroke, cerebral hemorrhage) * severe anemia (Hb \< 7) * pregnant women * patients with immunodeficiency * those taking steroids; and patients with chronic inflammatory diseases.

Design outcomes

Primary

MeasureTime frameDescription
Ultrasonography measurements20 weekabdominal muscles
Frailty20 weeksFRAIL scale: The FRAIL scale consists of 5 items, each scored on a scale of 0-1. The total score ranges from 0 to 5. Based on the total score, 0 is classified as robust/non-frail, 1-2 as prefrail, and 3 as frail.
Frailty 220 weeksclinic frailty scale:Participants' levels of frailty were assessed using the CFS, a scale with established Turkish validity and reliability. The CFS is a scale rated on a scale of 1 to 9, taking into account an individual's independence in activities of daily living and need for assistance. Higher numbers indicate a higher level of frailty.
total antioxidant status20 weekstotal antioxidant status :TAS levels were measured using commercial kits (Rel Assay Diagnostics, Turkey). Results were recorded in mmol Trolox equivalent/L.
total oxidant status20 weektotal oxidant status : TOS levels were measured using commercial kits (Rel Assay Diagnostics, Turkey). Results were recorded in μmol H₂O₂ equivalent/L.

Secondary

MeasureTime frameDescription
kinesiophobia20 weektampa scale: This is a Turkish-language measure with established validity and reliability that we use to assess participants' fears related to physical activity and movement. The scale consists of 17 items, each rated on a scale of 1 to 4. A higher score indicates a greater level of fear of movement.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 9, 2026