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Evaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management (METABAR)

8 giugno 2026 aggiornato da: Betül Gülşen, Toros University

Evaluation of Postoperative Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms in Body Weight Management After Laparoscopic Sleeve Gastrectomy

This study aims to evaluate the changes in metabolic parameters, intestinal permeability, and gastrointestinal symptoms in individuals who have undergone bariatric surgery (Laparoscopic Sleeve Gastrectomy - LSG) for obesity treatment.

Obesity is a chronic disease associated with serious health complications including type 2 diabetes, hypertension, cardiovascular disease, and metabolic disorders. Bariatric surgery is currently the most effective treatment method for morbid obesity. However, monitoring patients after surgery in terms of metabolic health, gut permeability, and gastrointestinal symptoms is crucial for long-term success.

In this study, 40 volunteers (aged 19-50) who have undergone LSG surgery within the last month will be followed for 6 months. At the beginning of the study and 6 months later, the following will be assessed:

  • Metabolic parameters: fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels
  • Intestinal permeability markers: zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels
  • Gastrointestinal symptoms: assessed using the Gastrointestinal Symptom Rating Scale (GSRS)
  • Anthropometric measurements: body weight, height, waist and hip circumference, BMI
  • Nutritional intake: 3-day dietary records

The study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic. Results will contribute to understanding the relationship between bariatric surgery and gut health, potentially helping to prevent postoperative complications.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Obesity is defined by the World Health Organization (WHO) as abnormal or excessive fat accumulation that presents a risk to health. Bariatric surgery, particularly Laparoscopic Sleeve Gastrectomy (LSG), is considered the most effective long-term treatment for morbid obesity.

This prospective observational study will be conducted at Bursa Yıldırım Doruk Hospital with 40 volunteers who have undergone LSG within the last month. Participants will be evaluated at baseline (immediately after surgery) and at 6 months post-surgery.

Assessments include:

  1. Anthropometric Measurements: Body weight, height, waist and hip circumference will be measured. BMI and waist-to-hip ratio will be calculated according to WHO criteria.
  2. Biochemical Parameters: Fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels will be obtained from patient records. Zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels will be analyzed using ELISA method (Biotek TS800) with commercial kits (RelAssay® Diagnostics, Ankara, Turkey) at Ankara Diagen Laboratory. Samples will be stored at -20°C until analysis.
  3. Gastrointestinal Symptom Rating Scale (GSRS): A validated 15-item scale assessing five dimensions: diarrhea, indigestion, constipation, abdominal pain, and reflux. Scores range from 1 (no discomfort) to 7 (very severe discomfort). Turkish validity and reliability was established by Turan and Asti (2011).
  4. Dietary Assessment: 3-day dietary records will be collected and analyzed using the Nutrition Information System (BeBIS) 8.2 software. Results will be evaluated according to the Turkish Dietary Guidelines 2022 (TUBER 2022).

Statistical analyses will be performed using the Statistical Package for the Social Sciences (SPSS) 22.0. Normal distribution will be assessed using Kolmogorov-Smirnov/Shapiro-Wilk tests. Results will be expressed as mean ± standard deviation for continuous variables and frequency/percentage for categorical variables.

Tipo di studio

Osservativo

Iscrizione (Stimato)

40

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Turchia (Türkiye)
    • Bursa
      • Bursa, Bursa, Turchia (Türkiye), 16310
        • Bursa Yıldırım Doruk Hospital
        • Investigatore principale:
          • Özlem ÖZPAK AKKUŞ, Assoc. Prof.
        • Sub-investigatore:
          • Doğukan Durak, Assoc. Prof.
        • Sub-investigatore:
          • Seher ŞEN, Asst. Prof.
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Betül GÜLŞEN, Assoc. Prof.
        • Sub-investigatore:
          • Tuğçe Nur Doganay Yıldırım, MSc, RD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adults with morbid obesity who underwent Laparoscopic Sleeve Gastrectomy (LSG) at Bursa Yıldırım Doruk Hospital General Surgery Clinic within the last month, meeting the inclusion criteria.

Descrizione

Inclusion Criteria:

  • Underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last 1 month
  • Aged between 19-50 years
  • BMI ≥40 kg/m² or BMI ≥35 kg/m² with obesity-related comorbidities
  • Signed informed consent form
  • Non-smoker and non-alcohol dependent

Exclusion Criteria:

  • Did not undergo or is not planned to undergo LSG
  • Outside the age range of 19-50 years
  • Did not sign the informed consent form
  • BMI <40 kg/m² or BMI <35 kg/m² without obesity-related comorbidities
  • Smoker or alcohol dependent
  • Has an inflammatory disease
  • Currently using probiotics, antibiotics, or fiber supplements
  • Has a psychiatric disorder

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
LSG Group
Adults aged 19-50 years who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital. Participants will be evaluated at baseline and 6 months after surgery for metabolic parameters, intestinal permeability markers, gastrointestinal symptoms, anthropometric measurements, and dietary intake.
Altro: Clinical and Biochemical Assessment
Participants will undergo two assessment visits: at baseline (within 1 month post-surgery) and at 6-month follow-up. Each visit includes anthropometric measurements (body weight, height, waist and hip circumference, BMI), biochemical blood analysis (fasting glucose, lipid profile, insulin, zonulin, secretory IgA, LPS), gastrointestinal symptom evaluation via GSRS, and 3-day dietary records.
Altri nomi:
  • Anthropometric Measurement
  • Biochemical Blood Analysis
  • Gastrointestinal Symptom Rating Scale (GSRS)
  • 3-Day Dietary Record
  • Intestinal Permeability Assessment

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Fasting Blood Glucose Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months
Change in serum fasting blood glucose levels after 12-hour fasting between baseline and 6-month follow-up.
Baseline and 6 months
Change in Total Cholesterol Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months
Change in serum total cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
Baseline and 6 months
Change in Triglyceride Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months
Change in serum triglyceride levels after 12-hour fasting between baseline and 6-month follow-up.
Baseline and 6 months
Change in HDL Cholesterol Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months
Change in serum high-density lipoprotein (HDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
Baseline and 6 months
Change in LDL Cholesterol Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months
Change in serum low-density lipoprotein (LDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
Baseline and 6 months
Change in VLDL Cholesterol Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months
Change in serum very low-density lipoprotein (VLDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
Baseline and 6 months
Change in Fasting Insulin Concentration (µIU/mL)
Lasso di tempo: Baseline and 6 months
Change in serum fasting insulin levels after 12-hour fasting between baseline and 6-month follow-up.
Baseline and 6 months
Change in Serum Zonulin Concentration (ng/mL)
Lasso di tempo: Baseline and 6 months
Change in serum zonulin levels assessed by ELISA method between baseline and 6-month follow-up.
Baseline and 6 months
Change in Serum Secretory IgA Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months
Change in serum secretory IgA levels assessed by ELISA method between baseline and 6-month follow-up.
Baseline and 6 months
Change in Serum LPS Concentration (EU/mL)
Lasso di tempo: Baseline and 6 months
Change in serum lipopolysaccharide (LPS) levels assessed by ELISA method between baseline and 6-month follow-up.
Baseline and 6 months
Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score (1-7)
Lasso di tempo: Baseline and 6 months
Change in total score of the Gastrointestinal Symptom Rating Scale (GSRS) between baseline and 6-month follow-up. The scale consists of 15 items across 5 subscales; scores range from 1 to 7, with higher scores indicating more severe gastrointestinal symptoms.
Baseline and 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Weight (kg)
Lasso di tempo: Baseline and 6 months
Change in body weight between baseline and 6-month follow-up.
Baseline and 6 months
Change in Body Mass Index (kg/m²)
Lasso di tempo: Baseline and 6 months
Change in BMI between baseline and 6-month follow-up. Weight and height will be combined to report BMI in kg/m².
Baseline and 6 months
Change in Waist Circumference (cm)
Lasso di tempo: Baseline and 6 months
Change in waist circumference between baseline and 6-month follow-up.
Baseline and 6 months
Change in Hip Circumference (cm)
Lasso di tempo: Baseline and 6 months
Change in hip circumference between baseline and 6-month follow-up.
Baseline and 6 months
Change in Waist-to-Hip Ratio
Lasso di tempo: Baseline and 6 months
Change in waist-to-hip ratio between baseline and 6-month follow-up. Waist and hip circumference measurements will be combined to calculate the waist-to-hip ratio.
Baseline and 6 months
Change in Daily Energy Intake (kcal/day)
Lasso di tempo: Baseline and 6 months
Change in daily energy intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software.
Baseline and 6 months
Change in Daily Protein Intake (g/day)
Lasso di tempo: Baseline and 6 months
Change in daily protein intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software.
Baseline and 6 months
Change in Daily Carbohydrate Intake (g/day)
Lasso di tempo: Baseline and 6 months
Change in daily carbohydrate intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software.
Baseline and 6 months
Change in Daily Fat Intake (g/day)
Lasso di tempo: Baseline and 6 months
Change in daily fat intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software.
Baseline and 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Toros University

Investigatori

  • Investigatore principale: Betül GÜLŞEN, Assoc. Prof., Toros University
  • Cattedra di studio: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University
  • Direttore dello studio: Doğukan DURAK, Assoc. Prof., Bursa Yıldırım Doruk Hospital, General Surgery Clinic

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

20 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

11 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • BCKLY-BGP-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared due to ethical considerations and participant confidentiality. Data will be stored securely and used only for the purposes of this study in accordance with Turkish Personal Data Protection Law (KVKK) and the ethical approval pending from Toros University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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