- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07636239
Eating Behavior, Nutritional Status and Appetite Hormones After Bariatric Surgery (BCKYL-YDB)
Evaluation of Changes in Postoperative Eating Behavior Attitudes, Nutritional Status, and Some Hormonal Parameters Regulating Appetite in Surgical Weight Management
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- Numer telefonu: +903246253300
- E-mail: dytozlemozpak@hotmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Doğukan DURAK, Assoc. Prof.
- Numer telefonu: +905327243733
- E-mail: dogukandurak404@hotmail.com
Lokalizacje studiów
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Bursa
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Bursa, Bursa, Turcja (Türkiye), 16130
- Bursa Yıldırım Doruk Hastanesi, General Surgery Clinic
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Kontakt:
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- Numer telefonu: +903246253300
- E-mail: dytozlemozpak@hotmail.com
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Kontakt:
- Doğukan DURAK, Assoc. Prof.
- Numer telefonu: +905327243733
- E-mail: dogukandurak404@hotmail.com
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Główny śledczy:
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
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Pod-śledczy:
- Doğukan Durak, Assoc. Prof.
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Pod-śledczy:
- Seher ŞEN, Asst. Prof.
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Pod-śledczy:
- Tuğçe Nur DOĞANAY YILDIRIM, MSc, RD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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.
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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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Serum Ghrelin Concentration (pg/mL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in serum ghrelin levels between baseline and 6-month follow-up, assessed by ELISA method.
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Baseline and 6 months after surgery
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Change in Serum GLP-1 Concentration (pmol/L)
Ramy czasowe: Baseline and 6 months after surgery
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Change in serum glucagon-like peptide-1 (GLP-1) levels between baseline and 6-month follow-up, assessed by ELISA method.
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Baseline and 6 months after surgery
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Change in Serum PYY Concentration (pg/mL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in serum peptide YY (PYY) levels between baseline and 6-month follow-up, assessed by ELISA method.
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Baseline and 6 months after surgery
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Change in Adult Eating Behavior Scale Total Score (0-100)
Ramy czasowe: Baseline and 6 months after surgery
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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.
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Baseline and 6 months after surgery
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Change in Daily Energy Intake (kcal/day)
Ramy czasowe: Baseline and 6 months after surgery
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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.
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Baseline and 6 months after surgery
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Change in Daily Protein Intake (g/day)
Ramy czasowe: Baseline and 6 months after surgery
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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
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Baseline and 6 months after surgery
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Change in Daily Carbohydrate Intake (g/day)
Ramy czasowe: Baseline and 6 months after surgery
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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.
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Baseline and 6 months after surgery
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Change in Daily Fat Intake (g/day)
Ramy czasowe: Baseline and 6 months after surgery
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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.
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Baseline and 6 months after surgery
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Body Weight (kg)
Ramy czasowe: Baseline and 6 months after surgery
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Change in body weight between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Body Mass Index (kg/m²)
Ramy czasowe: Baseline and 6 months after surgery
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Change in BMI between baseline and 6-month follow-up.
Weight and height will be combined to report BMI in kg/m².
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Baseline and 6 months after surgery
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Change in Waist Circumference (cm)
Ramy czasowe: Baseline and 6 months after surgery
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Change in waist circumference between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Hip Circumference (cm)
Ramy czasowe: Baseline and 6 months after surgery
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Change in hip circumference between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Waist-to-Hip Ratio
Ramy czasowe: Baseline and 6 months after surgery
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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.
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Baseline and 6 months after surgery
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Change in Fasting Blood Glucose Concentration (mg/dL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in fasting blood glucose levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Total Cholesterol Concentration (mg/dL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in total cholesterol levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Triglyceride Concentration (mg/dL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in triglyceride levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in HDL Cholesterol Concentration (mg/dL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in high-density lipoprotein (HDL) cholesterol levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in LDL Cholesterol Concentration (mg/dL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in low-density lipoprotein (LDL) cholesterol levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in VLDL Cholesterol Concentration (mg/dL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in very low-density lipoprotein (VLDL) cholesterol levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Fasting Insulin Concentration (µIU/mL)
Ramy czasowe: Baseline and 6 months after surgery
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Change in fasting insulin levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University
Publikacje i pomocne linki
Publikacje ogólne
- Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
- Sherf Dagan S, Goldenshluger A, Globus I, Schweiger C, Kessler Y, Kowen Sandbank G, Ben-Porat T, Sinai T. Nutritional Recommendations for Adult Bariatric Surgery Patients: Clinical Practice. Adv Nutr. 2017 Mar 15;8(2):382-394. doi: 10.3945/an.116.014258. Print 2017 Mar.
- Celik E, Karabulut E, Bilgic P. Bariatrik Cerrahi Hastalarinda Beslenme ve Davranis Tutumu Olcegi. Bes Diy Derg. 2017;45(2):107-15.
- Pekcan G, Sanlier N, Bas M, Acar Tek N, Gokmen Ozel H. Turkiye Beslenme Rehberi (TUBER) 2022. Ankara: Hazar Reklamcilik; 2022.
- Beslenme Bilgi Sistemleri Paket Programi (BeBIS 8.2). Istanbul: Software NDB; 2015.
- Merdol TK. Toplu Beslenme Yapilan Kurumlar icin Standard Yemek Tarifleri. Hatipoglu Yayinlari; 2003.
- Rakicioglu N, Tek NA, Ayaz A, Pekcan G. Yemek ve Besin Fotograf Katalogu Olcu ve Miktarlar. Nadir Kitap; 2012.
- Pekcan G. Beslenme Durumunun Saptanmasi. Diyet El Kitabi. Ankara: Hatipoglu Yayinevi; 2013:67-142.
- Baltaci G. Obezite ve egzersiz. Saglik Bakanligi Yayinlari, Ankara; 2008.
- World Health Organization. Prevention and management of the global epidemic of obesity. Report of the WHO Consultation on Obesity. Geneva: WHO; 1997.
- Rigamonti AE, Bini S, Rocco MC, Giardini V, Massimini D, Crippa MG, Saluzzi A, Casati M, Marazzi N, Perotti M, Cimino V, Grassi G, Sartorio A, Pincelli AI. Post-prandial anorexigenic gut peptide, appetite and glucometabolic responses at different eating rates in obese patients undergoing laparoscopic sleeve gastrectomy. Endocrine. 2017 Jan;55(1):113-123. doi: 10.1007/s12020-016-0933-6. Epub 2016 Mar 29.
- Devlin MJ, Goldfein JA, Flancbaum L, Bessler M, Eisenstadt R. Surgical management of obese patients with eating disorders: a survey of current practice. Obes Surg. 2004 Oct;14(9):1252-7. doi: 10.1381/0960892042386940.
- Brown W, Dixon JB, Brien PO. Management of obesity--the role of surgery. Aust Fam Physician. 2006 Aug;35(8):584-6.
- Katsanos CS, Madura JA 2nd, Roust LR. Essential amino acid ingestion as an efficient nutritional strategy for the preservation of muscle mass following gastric bypass surgery. Nutrition. 2016 Jan;32(1):9-13. doi: 10.1016/j.nut.2015.07.005. Epub 2015 Aug 5.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Zaburzenia odżywiania
- Przekarmienie
- Masy ciała
- Zmiany masy ciała
- Nadwaga
- Stany patologiczne, oznaki i objawy
- Zachowanie
- Choroby żywieniowe i metaboliczne
- Objawy i symptomy
- Zachowanie, zwierzę
- Otyłość
- Utrata masy ciała
- Zachowanie żywieniowe
- Jakość opieki zdrowotnej, dostęp i ocena
- Techniki śledcze
- Metody epidemiologiczne
- Zbieranie danych
- Mechanizmy oceny opieki zdrowotnej
- Jakość opieki zdrowotnej
- Zdrowie publiczne
- Środowisko i zdrowie publiczne
- Pomiary epidemiologiczne
- Ocena żywienia
Inne numery identyfikacyjne badania
- BCKLY-YDB-2026
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Anthropometric Measurements and Dietary Assessment
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Sarah Wragge WellnessZakończonySyndrom metabliczny | Otyłość i nadwaga | Zapobieganie cukrzycy typu 2 | Monitorowanie poziomu glukozy we krwiStany Zjednoczone