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

2. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

40

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Turecko (Türkiye)
    • Bursa
      • Bursa, Bursa, Turecko (Türkiye), 16130
        • Bursa Yıldırım Doruk Hastanesi, General Surgery Clinic
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Özlem ÖZPAK AKKUŞ, Assoc. Prof.
        • Dílčí vyšetřovatel:
          • Doğukan Durak, Assoc. Prof.
        • Dílčí vyšetřovatel:
          • Seher ŞEN, Asst. Prof.
        • Dílčí vyšetřovatel:
          • Tuğçe Nur DOĞANAY YILDIRIM, MSc, RD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Jiný: 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.
Ostatní jména:
  • Biochemical and Hormonal Parameter Analysis
  • Adult Eating Behavior Scale
  • 3-Day Dietary Intake Record

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Serum Ghrelin Concentration (pg/mL)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Body Weight (kg)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: Baseline and 6 months after surgery
Change in fasting insulin levels between baseline and 6-month follow-up.
Baseline and 6 months after surgery

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Özlem ÖZPAK AKKUŞ

Vyšetřovatelé

  • Vrchní vyšetřovatel: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. ledna 2027

Dokončení studie (Odhadovaný)

1. února 2027

Termíny zápisu do studia

První předloženo

20. května 2026

První předloženo, které splnilo kritéria kontroly kvality

2. června 2026

První zveřejněno (Aktuální)

9. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • BCKLY-YDB-2026

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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