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Eating Behavior, Nutritional Status and Appetite Hormones After Bariatric Surgery (BCKYL-YDB)

2. Juni 2026 aktualisiert von: Özlem ÖZPAK AKKUŞ

Evaluation of Changes in Postoperative Eating Behavior Attitudes, Nutritional Status, and Some Hormonal Parameters Regulating Appetite in Surgical Weight Management

This study aims to evaluate changes in eating behavior attitudes, nutritional status, and appetite-regulating hormonal parameters in individuals who have undergone Laparoscopic Sleeve Gastrectomy (LSG). The study will be conducted at Bursa Yıldırım Doruk Hospital, Department of General Surgery. A total of 40 volunteer participants who underwent LSG within the last month will be included. Participants will be assessed at baseline (shortly after surgery) and at 6-month follow-up. Assessments will include anthropometric measurements (body weight, height, waist and hip circumference, BMI, waist-to-hip ratio), 3-day dietary intake records analyzed using BeBIS 8.2 software, and the Adult Eating Behavior Scale. Biochemical parameters including fasting blood glucose, total cholesterol, triglycerides, HDL, LDL, VLDL cholesterol, and insulin will be obtained from patient files and analyzed using Advia Chemistry 2400 and Advia XPT devices. Additionally, appetite-regulating hormones (ghrelin, GLP-1, PYY) will be analyzed from residual blood samples using the ELISA method with RelAssay Diagnostics kits by Teknogen Bioengineering Laboratory. All data will be compared between baseline and 6-month follow-up to evaluate the impact of bariatric surgery on nutritional and hormonal outcomes.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This observational study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic, under the supervision of Assoc. Prof. Dogukan Durak. Forty volunteer participants who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month and meet the inclusion and exclusion criteria will be enrolled after signing an informed consent form.

Assessments will be performed at two time points: at baseline (shortly after surgery) and at 6-month follow-up.

Anthropometric Measurements: Body weight, height, waist and hip circumference will be measured. BMI and waist-to-hip ratio will be calculated accordingly. Waist circumference will be evaluated according to WHO criteria.

Dietary Assessment: A 3-day dietary intake record will be collected from each participant at both time points. Food portion sizes will be estimated using the "Food and Nutrient Photo Catalog." Energy and macronutrient intake will be analyzed using BeBIS 8.2 software and evaluated according to the Turkish Dietary Guidelines 2022 (TUBER 2022).

Eating Behavior Assessment: The Adult Eating Behavior Scale (developed by Celik et al.) will be administered at both time points. The scale consists of 18 items and 5 subscales, scored between 0-100. Higher scores indicate more positive attitudes toward eating behavior.

Biochemical and Hormonal Parameters: After 12-hour fasting, the following biochemical parameters will be obtained from patient files: fasting blood glucose (FBG), total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, and insulin. Routine biochemical parameters and lipid profile will be analyzed spectrophotometrically using the Advia Chemistry 2400 device, while insulin will be measured by chemiluminescence using the Advia XPT device. Additionally, appetite-regulating hormones including ghrelin, glucagon-like peptide-1 (GLP-1), and peptide YY (PYY) will be analyzed from residual blood samples stored at -20°C by Teknogen Bioengineering Laboratory using the ELISA method with an automated microplate reader (Biotek TS800) and RelAssay Diagnostics commercial kits (Ankara, Turkey).

All data will be compared between baseline and 6-month follow-up using appropriate statistical methods.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

40

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Türkei (türkiye)
    • Bursa
      • Bursa, Bursa, Türkei (türkiye), 16130
        • Bursa Yıldırım Doruk Hastanesi, General Surgery Clinic
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Özlem ÖZPAK AKKUŞ, Assoc. Prof.
        • Unterermittler:
          • Doğukan Durak, Assoc. Prof.
        • Unterermittler:
          • Seher ŞEN, Asst. Prof.
        • Unterermittler:
          • Tuğçe Nur DOĞANAY YILDIRIM, MSc, RD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult patients who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital, General Surgery Clinic, under the supervision of Assoc. Prof. Dogukan Durak, and who meet the inclusion and exclusion criteria.

Beschreibung

Inclusion Criteria:

  • Having undergone Laparoscopic Sleeve Gastrectomy (LSG) within the last month
  • Aged between 18-50 years
  • Signing the informed consent form
  • Having a Body Mass Index (BMI) of 40 kg/m2 or between 35-40 kg/m2 with obesity-related comorbidities
  • No diagnosis of depression
  • No eating behavior disorder
  • No psychiatric disorder

Exclusion Criteria:

  • Not having undergone Laparoscopic Sleeve Gastrectomy (LSG) or not planning to undergo bariatric surgery
  • Not being in the age range of 18-50 years
  • Not signing the informed consent form
  • Having a Body Mass Index (BMI) greater than 40 kg/m2 or less than 35 kg/m2 without obesity-related comorbidities
  • Having a diagnosis of depression
  • Having an eating behavior disorder
  • Having a psychiatric disorder

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
LSG Patients
Individuals who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital, General Surgery Clinic, and meet the inclusion and exclusion criteria. Participants will be assessed at baseline (shortly after surgery) and at 6-month follow-up.
Sonstiges: Anthropometric Measurements and Dietary Assessment
Anthropometric measurements (body weight, height, waist and hip circumference, BMI, waist-to-hip ratio), 3-day dietary intake records, Adult Eating Behavior Scale, and biochemical and hormonal parameters (fasting blood glucose, lipid profile, insulin, ghrelin, GLP-1, PYY) will be assessed at baseline and at 6-month follow-up.
Andere Namen:
  • Biochemical and Hormonal Parameter Analysis
  • Adult Eating Behavior Scale
  • 3-Day Dietary Intake Record

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Serum Ghrelin Concentration (pg/mL)
Zeitfenster: Baseline and 6 months after surgery
Change in serum ghrelin levels between baseline and 6-month follow-up, assessed by ELISA method.
Baseline and 6 months after surgery
Change in Serum GLP-1 Concentration (pmol/L)
Zeitfenster: Baseline and 6 months after surgery
Change in serum glucagon-like peptide-1 (GLP-1) levels between baseline and 6-month follow-up, assessed by ELISA method.
Baseline and 6 months after surgery
Change in Serum PYY Concentration (pg/mL)
Zeitfenster: Baseline and 6 months after surgery
Change in serum peptide YY (PYY) levels between baseline and 6-month follow-up, assessed by ELISA method.
Baseline and 6 months after surgery
Change in Adult Eating Behavior Scale Total Score (0-100)
Zeitfenster: Baseline and 6 months after surgery
Change in Adult Eating Behavior Scale total score between baseline and 6-month follow-up. Scale is scored between 0-100; higher scores indicate more positive eating behavior attitudes.
Baseline and 6 months after surgery
Change in Daily Energy Intake (kcal/day)
Zeitfenster: Baseline and 6 months after surgery
Change in daily energy intake assessed by 3-day dietary intake records at baseline and 6-month follow-up. Food portions will be estimated using the Food and Nutrient Photo Catalog. Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
Baseline and 6 months after surgery
Change in Daily Protein Intake (g/day)
Zeitfenster: Baseline and 6 months after surgery
Change in daily protein intake assessed by 3-day dietary intake records at baseline and 6-month follow-up. Food portions will be estimated using the Food and Nutrient Photo Catalog. Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022
Baseline and 6 months after surgery
Change in Daily Carbohydrate Intake (g/day)
Zeitfenster: Baseline and 6 months after surgery
Change in daily carbohydrate intake assessed by 3-day dietary intake records at baseline and 6-month follow-up. Food portions will be estimated using the Food and Nutrient Photo Catalog. Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
Baseline and 6 months after surgery
Change in Daily Fat Intake (g/day)
Zeitfenster: Baseline and 6 months after surgery
Change in daily fat intake assessed by 3-day dietary intake records at baseline and 6-month follow-up. Food portions will be estimated using the Food and Nutrient Photo Catalog. Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
Baseline and 6 months after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Body Weight (kg)
Zeitfenster: Baseline and 6 months after surgery
Change in body weight between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Body Mass Index (kg/m²)
Zeitfenster: Baseline and 6 months after surgery
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 after surgery
Change in Waist Circumference (cm)
Zeitfenster: Baseline and 6 months after surgery
Change in waist circumference between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Hip Circumference (cm)
Zeitfenster: Baseline and 6 months after surgery
Change in hip circumference between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Waist-to-Hip Ratio
Zeitfenster: Baseline and 6 months after surgery
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 after surgery
Change in Fasting Blood Glucose Concentration (mg/dL)
Zeitfenster: Baseline and 6 months after surgery
Change in fasting blood glucose levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Total Cholesterol Concentration (mg/dL)
Zeitfenster: Baseline and 6 months after surgery
Change in total cholesterol levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Triglyceride Concentration (mg/dL)
Zeitfenster: Baseline and 6 months after surgery
Change in triglyceride levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in HDL Cholesterol Concentration (mg/dL)
Zeitfenster: Baseline and 6 months after surgery
Change in high-density lipoprotein (HDL) cholesterol levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in LDL Cholesterol Concentration (mg/dL)
Zeitfenster: Baseline and 6 months after surgery
Change in low-density lipoprotein (LDL) cholesterol levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in VLDL Cholesterol Concentration (mg/dL)
Zeitfenster: Baseline and 6 months after surgery
Change in very low-density lipoprotein (VLDL) cholesterol levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery
Change in Fasting Insulin Concentration (µIU/mL)
Zeitfenster: Baseline and 6 months after surgery
Change in fasting insulin levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Özlem ÖZPAK AKKUŞ

Ermittler

  • Hauptermittler: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

20. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BCKLY-YDB-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared due to patient privacy and confidentiality concerns in accordance with Turkish Personal Data Protection Law (KVKK). Aggregate study results will be made available through peer-reviewed publication.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Bedingungen

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Standorte

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