NCT07854275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

abdominal musclechronic kidney diseasemonocyte chemoattractant protein-1total antioxidant statustotal oxidant status

Outcome Measures

Primary Outcomes (5)

  • Ultrasonography measurements

    abdominal muscles

    20 week

  • Frailty

    FRAIL scale

    20 weeks

  • Frailty 2

    clinic frailty scale

    20 weeks

  • total antioxidant status

    total antioxidant status

    20 weeks

  • total oxidant status

    total oxidant status

    20 week

Secondary Outcomes (1)

  • kinesiophobia

    20 week

Study Arms (3)

stage 3

chronic kidney disease stage 3

Other: total antioxidant statusOther: total oxidant statusOther: monocyte chemotactic protein-1Other: ultrasonography muscleOther: FRAIL scaleOther: clinical frailty scaleOther: tampa scale

stage 4

chronic kidney disease stage 4

Other: total antioxidant statusOther: total oxidant statusOther: monocyte chemotactic protein-1Other: ultrasonography muscleOther: FRAIL scaleOther: clinical frailty scaleOther: tampa scale

stage 5

chronic kidney disease stage 5

Other: total antioxidant statusOther: total oxidant statusOther: monocyte chemotactic protein-1Other: ultrasonography muscleOther: FRAIL scaleOther: clinical frailty scaleOther: tampa scale

Interventions

total antioxidant status

stage 3stage 4stage 5

total oxidant status

stage 3stage 4stage 5

monocyte chemotactic protein-1

stage 3stage 4stage 5

abdominal muscles

stage 3stage 4stage 5

frailty

stage 3stage 4stage 5

frailty

stage 3stage 4stage 5

kinesiophobia

stage 3stage 4stage 5

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

18-70 years stage 3-5 CKD

You may qualify if:

  • Be between 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Training and Research hospital

Samsun, Turkey (Türkiye)

Location

Related Publications (7)

  • Yousefzadeh MJ, Schafer MJ, Noren Hooten N, Atkinson EJ, Evans MK, Baker DJ, Quarles EK, Robbins PD, Ladiges WC, LeBrasseur NK, Niedernhofer LJ. Circulating levels of monocyte chemoattractant protein-1 as a potential measure of biological age in mice and frailty in humans. Aging Cell. 2018 Apr;17(2):e12706. doi: 10.1111/acel.12706. Epub 2017 Dec 31.

    PMID: 29290100BACKGROUND
  • Beyer I, Njemini R, Bautmans I, Demanet C, Bergmann P, Mets T. Inflammation-related muscle weakness and fatigue in geriatric patients. Exp Gerontol. 2012 Jan;47(1):52-9. doi: 10.1016/j.exger.2011.10.005. Epub 2011 Oct 18.

    PMID: 22032874BACKGROUND
  • Schettini IVG, Faria DV, Nogueira LS, Otoni A, Silva ACSE, Rios DRA. Renin angiotensin system molecules and chemokine (C-C motif) ligand 2 (CCL2) in chronic kidney disease patients. J Bras Nefrol. 2022 Jan-Mar;44(1):19-25. doi: 10.1590/2175-8239-JBN-2021-0030.

    PMID: 34251390BACKGROUND
  • Watanabe H, Enoki Y, Maruyama T. Sarcopenia in Chronic Kidney Disease: Factors, Mechanisms, and Therapeutic Interventions. Biol Pharm Bull. 2019;42(9):1437-1445. doi: 10.1248/bpb.b19-00513.

    PMID: 31474705BACKGROUND
  • Chao CT, Kovesdy CP, Merchant RA. Sarcopenia, sarcopenic obesity, and frailty in individuals with chronic kidney disease: a comprehensive review. Kidney Res Clin Pract. 2026 Mar;45(2):174-188. doi: 10.23876/j.krcp.24.207. Epub 2025 Jan 21.

    PMID: 39973319BACKGROUND
  • Wang XH, Mitch WE. Mechanisms of muscle wasting in chronic kidney disease. Nat Rev Nephrol. 2014 Sep;10(9):504-16. doi: 10.1038/nrneph.2014.112. Epub 2014 Jul 1.

    PMID: 24981816BACKGROUND
  • Bello AK, Alrukhaimi M, Ashuntantang GE, Basnet S, Rotter RC, Douthat WG, Kazancioglu R, Kottgen A, Nangaku M, Powe NR, White SL, Wheeler DC, Moe O. Complications of chronic kidney disease: current state, knowledge gaps, and strategy for action. Kidney Int Suppl (2011). 2017 Oct;7(2):122-129. doi: 10.1016/j.kisu.2017.07.007. Epub 2017 Sep 20.

    PMID: 30675426BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicFrailty

Interventions

Chemokine CCL2

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monocyte Chemoattractant ProteinsChemokines, CCChemokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsChemotactic FactorsBiological FactorsInflammation Mediators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist medical doctor

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start

January 15, 2025

Primary Completion

May 15, 2025

Study Completion

August 1, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Locations