NCT07655739

Brief Summary

Fractalkine (CX3CL1) is a unique chemokine involved in leukocyte adhesion, migration, and obesity-associated adipose tissue inflammation. Although bariatric surgery results in substantial weight loss and metabolic improvement, the temporal pattern of circulating CX3CL1 levels following laparoscopic sleeve gastrectomy (LSG) remains poorly understood. This study aimed to evaluate longitudinal changes in serum CX3CL1 levels after LSG and to investigate their association with postoperative weight loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

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

September 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 13, 2026

Last Update Submit

June 13, 2026

Conditions

Keywords

FractalkineCX3CL1Sleeve gastrectomyMorbid obesityWeight lossInflammation

Outcome Measures

Primary Outcomes (2)

  • Fractalcine levels changes after laparoscopic sleeve gastrectomy

    Fractalcine levels changes between preoperative and postop operative third month

    3 months

  • Weight lost levels after obesity surgery

    Preoperative and the postoperative third month's Total weight lost percentage and excess weight loss percentage were calculated.

    3 months

Study Arms (1)

Obesity Surgery Patients undergoing Laparoscopic Sleeve Gastrectomy

Obesity Surgery Patients undergoing Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

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

Patients with a body mass index (BMI) ≥40 kg/m² or a BMI ≥35 kg/m² in the presence of at least one obesity-related comorbidity who were planned for Laparoscopic Sleeve Gastrectomy.

You may qualify if:

  • Age ≥18 years
  • Elective laparoscopic sleeve gastrectomy
  • Provision of written informed consent for study participation and scheduled follow-up assessments

You may not qualify if:

  • Active infection or acute inflammatory condition
  • Autoimmune or chronic inflammatory disease
  • History of malignancy
  • Chronic liver or kidney disease
  • Pregnancy or lactation
  • Corticosteroid or immunosuppressive therapy
  • Major postoperative complications
  • Missing data or incomplete sampling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elazig Fethi Sekin City Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (17)

  • Polyak A, Ferenczi S, Denes A, Winkler Z, Kriszt R, Pinter-Kubler B, Kovacs KJ. The fractalkine/Cx3CR1 system is implicated in the development of metabolic visceral adipose tissue inflammation in obesity. Brain Behav Immun. 2014 May;38:25-35. doi: 10.1016/j.bbi.2014.01.010. Epub 2014 Jan 21.

    PMID: 24456845BACKGROUND
  • Swalsingh G, Pani P, Sadayappan S, Bal NC. Fractalkine is a key player in skeletal muscle metabolism and pathophysiology. FEBS J. 2026 Apr;293(7):1865-1881. doi: 10.1111/febs.70267. Epub 2025 Sep 25.

    PMID: 40995677BACKGROUND
  • Sirois-Gagnon D, Chamberland A, Perron S, Brisson D, Gaudet D, Laprise C. Association of common polymorphisms in the fractalkine receptor (CX3CR1) with obesity. Obesity (Silver Spring). 2011 Jan;19(1):222-7. doi: 10.1038/oby.2010.125. Epub 2010 Jun 3.

    PMID: 20523302BACKGROUND
  • Cefalu WT. Fractalkine: a cellular link between adipose tissue inflammation and vascular pathologies. Diabetes. 2011 May;60(5):1380-2. doi: 10.2337/db11-0239. No abstract available.

    PMID: 21525509BACKGROUND
  • Morris DL, Oatmen KE, Wang T, DelProposto JL, Lumeng CN. CX3CR1 deficiency does not influence trafficking of adipose tissue macrophages in mice with diet-induced obesity. Obesity (Silver Spring). 2012 Jun;20(6):1189-99. doi: 10.1038/oby.2012.7. Epub 2012 Jan 17.

    PMID: 22252034BACKGROUND
  • Shah R, Hinkle CC, Ferguson JF, Mehta NN, Li M, Qu L, Lu Y, Putt ME, Ahima RS, Reilly MP. Fractalkine is a novel human adipochemokine associated with type 2 diabetes. Diabetes. 2011 May;60(5):1512-8. doi: 10.2337/db10-0956.

    PMID: 21525510BACKGROUND
  • Rivera-Carranza T, Azaola-Espinosa A, Bojalil-Parra R, Zuniga-Leon E, Leon-Tellez-Giron A, Rojano-Rodriguez ME, Najera-Medina O. Immunometabolic Changes Following Gastric Bypass and Sleeve Gastrectomy: A Comparative Study. Obes Surg. 2025 Feb;35(2):481-495. doi: 10.1007/s11695-024-07598-3. Epub 2025 Jan 11.

    PMID: 39794663BACKGROUND
  • Subramaniam R, Aliakbarian H, Bhutta HY, Harris DA, Tavakkoli A, Sheu EG. Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Attenuate Pro-inflammatory Small Intestinal Cytokine Signatures. Obes Surg. 2019 Dec;29(12):3824-3832. doi: 10.1007/s11695-019-04059-0.

    PMID: 31363962BACKGROUND
  • Farsad F, Salimpour S, Mirhashemi S, Jolfaei P, Erfanifar A, Toreyhi H, Davoudi Z. Impact of BMI Reduction After Sleeve Surgery on ESR and CRP Levels in Patients with Obesity. Obes Surg. 2025 Apr;35(4):1307-1315. doi: 10.1007/s11695-025-07746-3. Epub 2025 Mar 3.

    PMID: 40025344BACKGROUND
  • Surve A, Cottam D, Pryor A, Cottam S, Michaelson R, Umbach T, Williams M, Bagshahi H, July L, Bueno R, Chock D, Apel M, Hart C, Johnson W, Curtis B, Rosenbluth A, Spaniolas K, Medlin W, Wright W, Lee C, Lee C, Trujeque R, Rinker D. A Prospective Multicenter Standard of Care Study of Outpatient Laparoscopic Sleeve Gastrectomy. Obes Surg. 2024 Apr;34(4):1122-1130. doi: 10.1007/s11695-024-07094-8. Epub 2024 Feb 17.

    PMID: 38366263BACKGROUND
  • Rohm TV, Meier DT, Olefsky JM, Donath MY. Inflammation in obesity, diabetes, and related disorders. Immunity. 2022 Jan 11;55(1):31-55. doi: 10.1016/j.immuni.2021.12.013.

    PMID: 35021057BACKGROUND
  • Zatterale F, Longo M, Naderi J, Raciti GA, Desiderio A, Miele C, Beguinot F. Chronic Adipose Tissue Inflammation Linking Obesity to Insulin Resistance and Type 2 Diabetes. Front Physiol. 2020 Jan 29;10:1607. doi: 10.3389/fphys.2019.01607. eCollection 2019.

    PMID: 32063863BACKGROUND
  • Crasan IM, Tanase M, Delia CE, Gradisteanu-Pircalabioru G, Cimpean A, Ionica E. Metaflammation's Role in Systemic Dysfunction in Obesity: A Comprehensive Review. Int J Mol Sci. 2025 Oct 27;26(21):10445. doi: 10.3390/ijms262110445.

    PMID: 41226484BACKGROUND
  • Engin A. Reappraisal of Adipose Tissue Inflammation in Obesity. Adv Exp Med Biol. 2024;1460:297-327. doi: 10.1007/978-3-031-63657-8_10.

    PMID: 39287856BACKGROUND
  • Ahmed B, Sultana R, Greene MW. Adipose tissue and insulin resistance in obese. Biomed Pharmacother. 2021 May;137:111315. doi: 10.1016/j.biopha.2021.111315. Epub 2021 Feb 6.

    PMID: 33561645BACKGROUND
  • Pati S, Irfan W, Jameel A, Ahmed S, Shahid RK. Obesity and Cancer: A Current Overview of Epidemiology, Pathogenesis, Outcomes, and Management. Cancers (Basel). 2023 Jan 12;15(2):485. doi: 10.3390/cancers15020485.

    PMID: 36672434BACKGROUND
  • Saltiel AR, Olefsky JM. Inflammatory mechanisms linking obesity and metabolic disease. J Clin Invest. 2017 Jan 3;127(1):1-4. doi: 10.1172/JCI92035. Epub 2017 Jan 3.

    PMID: 28045402BACKGROUND

MeSH Terms

Conditions

ObesityOverweightObesity, MorbidWeight LossInflammation

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesPathologic Processes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Associate

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 18, 2026

Study Start

September 4, 2025

Primary Completion

January 4, 2026

Study Completion

February 4, 2026

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations