NCT07636239

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

May 20, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

ObesityBariatric SurgeryLaparoscopic Sleeve GastrectomyEating BehaviorNutritional statusGhrelinGLP-1Peptite YYAppetite hormonesBody mass indexWeight lossDietary intake

Outcome Measures

Primary Outcomes (8)

  • Change in Serum Ghrelin Concentration (pg/mL)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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

Secondary Outcomes (12)

  • Change in Body Weight (kg)

    Baseline and 6 months after surgery

  • Change in Body Mass Index (kg/m²)

    Baseline and 6 months after surgery

  • Change in Waist Circumference (cm)

    Baseline and 6 months after surgery

  • Change in Hip Circumference (cm)

    Baseline and 6 months after surgery

  • Change in Waist-to-Hip Ratio

    Baseline and 6 months after surgery

  • +7 more secondary outcomes

Study Arms (1)

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.

Other: Anthropometric Measurements and Dietary Assessment

Interventions

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.

Also known as: Biochemical and Hormonal Parameter Analysis, Adult Eating Behavior Scale, 3-Day Dietary Intake Record
LSG Patients

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yıldırım Doruk Hastanesi, General Surgery Clinic

Bursa, Bursa, 16130, Turkey (Türkiye)

Location

Related Publications (14)

  • Celik E, Karabulut E, Bilgic P. Bariatrik Cerrahi Hastalarinda Beslenme ve Davranis Tutumu Olcegi. Bes Diy Derg. 2017;45(2):107-15.

    BACKGROUND
  • Pekcan G, Sanlier N, Bas M, Acar Tek N, Gokmen Ozel H. Turkiye Beslenme Rehberi (TUBER) 2022. Ankara: Hazar Reklamcilik; 2022.

    BACKGROUND
  • Beslenme Bilgi Sistemleri Paket Programi (BeBIS 8.2). Istanbul: Software NDB; 2015.

    BACKGROUND
  • Merdol TK. Toplu Beslenme Yapilan Kurumlar icin Standard Yemek Tarifleri. Hatipoglu Yayinlari; 2003.

    BACKGROUND
  • Rakicioglu N, Tek NA, Ayaz A, Pekcan G. Yemek ve Besin Fotograf Katalogu Olcu ve Miktarlar. Nadir Kitap; 2012.

    BACKGROUND
  • Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.

    PMID: 8594834BACKGROUND
  • Pekcan G. Beslenme Durumunun Saptanmasi. Diyet El Kitabi. Ankara: Hatipoglu Yayinevi; 2013:67-142.

    BACKGROUND
  • Baltaci G. Obezite ve egzersiz. Saglik Bakanligi Yayinlari, Ankara; 2008.

    BACKGROUND
  • World Health Organization. Prevention and management of the global epidemic of obesity. Report of the WHO Consultation on Obesity. Geneva: WHO; 1997.

    BACKGROUND
  • 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.

    PMID: 27022941BACKGROUND
  • 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.

    PMID: 15527644BACKGROUND
  • Brown W, Dixon JB, Brien PO. Management of obesity--the role of surgery. Aust Fam Physician. 2006 Aug;35(8):584-6.

    PMID: 16894430BACKGROUND
  • 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.

    PMID: 26456190BACKGROUND
  • 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.

    PMID: 28298280BACKGROUND

MeSH Terms

Conditions

ObesityFeeding BehaviorWeight Loss

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorBody Weight Changes

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Özlem ÖZPAK AKKUŞ, Assoc. Prof.

    Toros University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Özlem ÖZPAK AKKUŞ, Assoc. Prof.

CONTACT

Doğukan DURAK, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

May 20, 2026

First Posted

June 9, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations