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

8 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

40

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
    • Bursa
      • Bursa, Bursa, Turkije (Türkiye), 16310
        • Bursa Yıldırım Doruk Hospital
        • Hoofdonderzoeker:
          • Özlem ÖZPAK AKKUŞ, Assoc. Prof.
        • Onderonderzoeker:
          • Doğukan Durak, Assoc. Prof.
        • Onderonderzoeker:
          • Seher ŞEN, Asst. Prof.
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Betül GÜLŞEN, Assoc. Prof.
        • Onderonderzoeker:
          • Tuğçe Nur Doganay Yıldırım, MSc, RD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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.
Andere namen:
  • Anthropometric Measurement
  • Biochemical Blood Analysis
  • Gastrointestinal Symptom Rating Scale (GSRS)
  • 3-Day Dietary Record
  • Intestinal Permeability Assessment

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Fasting Blood Glucose Concentration (mg/dL)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Body Weight (kg)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Baseline and 6 months
Change in waist circumference between baseline and 6-month follow-up.
Baseline and 6 months
Change in Hip Circumference (cm)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Toros University

Onderzoekers

  • Hoofdonderzoeker: Betül GÜLŞEN, Assoc. Prof., Toros University
  • Studie stoel: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University
  • Studie directeur: Doğukan DURAK, Assoc. Prof., Bursa Yıldırım Doruk Hospital, General Surgery Clinic

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

20 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juni 2026

Eerst geplaatst (Werkelijk)

11 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BCKLY-BGP-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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