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FABP4 Response After Roux-en-Y Gastric Bypass

Heterogeneous Fatty Acid-Binding Protein 4 (FABP4) Responses After Roux-en-Y Gastric Bypass: A Retrospective Observational Cohort Study of Adipokine Remodeling Dissociated From Weight Loss, Inflammation, and Incretin Dynamics

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07774208
Acronym
FABP4-RYGB
Enrollment
28
Registered
2026-08-19
Start date
2013-04-22
Completion date
2015-02-10
Last updated
2026-08-19

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

Conditions

Bariatric Surgery, Bariatric Surgery (Gastric Bypass), Insulin Resistance, Obesity (BMI>30), Obesity (BMI > 35)

Keywords

FABP4, Roux-en-Y gastric bypass, adipokine, bariatric surgery, weight loss, adipose tissue remodeling, GLP-1, PYY, inflammation

Brief summary

This retrospective observational cohort study examined serum fatty acid-binding protein 4 (FABP4) dynamics in 28 adults who underwent Roux-en-Y gastric bypass (RYGB), followed at baseline, 3 months, and 6 months. Anthropometric, metabolic, and inflammatory parameters were assessed alongside FABP4, fasting GLP-1, and PYY. Patients were classified as FABP4 responders (decrease from baseline to 6 months) or rebound/non-responders. The study investigated whether FABP4 trajectory after RYGB is associated with the magnitude of weight loss, systemic inflammation, and fasting incretin change.

Detailed description

Sixteen of the 28 participants had previously been enrolled in the control (probiotic-only, non-prebiotic) arm of a completed, registered randomized trial of pre-/probiotic supplementation after RYGB at the same institution (ClinicalTrials.gov Identifier: NCT03517345); these participants received no prebiotic intervention. The remaining 12 participants underwent RYGB by the same surgeon during a comparable period and were not enrolled in that trial. Blood samples from both subgroups had originally been collected and stored at -80°C as part of their respective prospective clinical follow-up. FABP4 concentrations were subsequently measured in these banked, single freeze-thaw samples using a commercial ELISA assay, blinded to patients' weight-loss and inflammatory outcomes, and merged with the anthropometric and biochemical data collected at the corresponding original visits. Because FABP4 assay and the present statistical analysis were performed after clinical follow-up had already been completed for both subgroups, this study is registered retrospectively.

Interventions

None listed

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Adults who underwent Roux-en-Y gastric bypass (RYGB), performed by a single surgeon * Completed baseline, 3-month, and 6-month clinical and anthropometric assessments

Exclusion criteria

* Use of GLP-1 receptor agonists at any study time point * Use of insulin at any study time point * Missing 6-month FABP4 measurement (excluded from FABP4-based longitudinal/group analyses; n=1)

Design outcomes

Primary

MeasureTime frameDescription
Measure: Change in serum FABP4 level from baseline to 6 months after RYGBTime Frame: Baseline, 3 months, 6 monthsDescription: FABP4 measured by ELISA; patients classified as responders (decrease) vs. rebound/non-responders (no decrease or increase)

Secondary

MeasureTime frameDescription
Change in BMI from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in BMI from baseline to 3 and 6 months
Change in body weight from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in body weight from baseline to 3 and 6 months
Change in fat mass (bioelectrical impedance) from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in fat mass and fat-free mass (bioelectrical impedance) from baseline to 3 and 6 months
Change in fat-free mass (bioelectrical impedance) from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in fat mass and fat-free mass (bioelectrical impedance) from baseline to 3 and 6 months
Change in HOMA-IR from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in HOMA-IR from baseline to 3 and 6 months
Change in IL-6 from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in hsCRP and IL-6 from baseline to 3 and 6 months
Change in hsCRP from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in hsCRP and IL-6 from baseline to 3 and 6 months
Change in fasting GLP-1 from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in fasting GLP-1 and PYY from baseline to 3 and 6 months
Change in fasting PYY from baseline to 3 and 6 monthsBaseline, 3 months, 6 monthsChange in fasting GLP-1 and PYY from baseline to 3 and 6 months
Baseline-Adjusted 6-Month Change in Body Mass Index (BMI) by FABP4 Response GroupBaseline, 3 months, 6 months6-month change in BMI (kg/m²) was compared between FABP4 responder and rebound (non-responder) groups using an ANCOVA model adjusted for baseline (preoperative) serum FABP4 concentration (log-transformed). FABP4 response group was defined by the direction of change in serum FABP4, measured by enzyme-linked immunosorbent assay (ELISA), from baseline to 6 months after Roux-en-Y gastric bypass.
Odds Ratios for Predictors of 6-Month FABP4 Rebound: Early (0-3-Month) BMI Change, Age, and SexBaseline, 3 months, 6 monthsOdds ratios (OR) with 95% confidence intervals were estimated using a multivariable logistic regression model to identify predictors of FABP4 rebound status at 6 months after Roux-en-Y gastric bypass. Covariates included early (0-3-month) percentage change in body mass index (BMI), age (years), and sex (male/female). FABP4 rebound was defined as an increase in serum FABP4 concentration, measured by enzyme-linked immunosorbent assay (ELISA), from baseline to 6 months postoperatively.

Contacts

PRINCIPAL_INVESTIGATORBedia Fulya Calikoglu, M.D., PhD.

Istanbul University, Istanbul Medical Faculty

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026