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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

40

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tyrkiet (Türkiye)
    • Bursa
      • Bursa, Bursa, Tyrkiet (Türkiye), 16130
        • Bursa Yıldırım Doruk Hastanesi, General Surgery Clinic
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Özlem ÖZPAK AKKUŞ, Assoc. Prof.
        • Underforsker:
          • Doğukan DURAK, Assoc. Prof.
        • Underforsker:
          • Seher ŞEN, Asst. Prof.
        • Underforsker:
          • Tuğçe Nur DOĞANAY YILDIRIM, MSc, RD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: 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.
Andre navne:
  • Biochemical and Hormonal Parameter Analysis
  • Adult Eating Behavior Scale
  • 3-Day Dietary Intake Record

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Serum Ghrelin Concentration (pg/mL)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Weight (kg)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline and 6 months after surgery
Change in fasting insulin levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Özlem ÖZPAK AKKUŞ

Efterforskere

  • Ledende efterforsker: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. februar 2027

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BCKLY-YDB-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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