Eating Behavior, Nutritional Status and Appetite Hormones After Bariatric Surgery (BCKYL-YDB)
2026年6月2日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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.
研究の種類
観察的
入学 (推定)
40
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- 電話番号：+903246253300
- メール：dytozlemozpak@hotmail.com
研究連絡先のバックアップ
- 名前：Doğukan DURAK, Assoc. Prof.
- 電話番号：+905327243733
- メール：dogukandurak404@hotmail.com
研究場所
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Bursa
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Bursa、Bursa、トルコ（Türkiye）、16130
- Bursa Yıldırım Doruk Hastanesi, General Surgery Clinic
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コンタクト：
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- 電話番号：+903246253300
- メール：dytozlemozpak@hotmail.com
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コンタクト：
- Doğukan DURAK, Assoc. Prof.
- 電話番号：+905327243733
- メール：dogukandurak404@hotmail.com
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主任研究者：
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
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副調査官：
- Doğukan Durak, Assoc. Prof.
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副調査官：
- Seher ŞEN, Asst. Prof.
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副調査官：
- Tuğçe Nur DOĞANAY YILDIRIM, MSc, RD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Serum Ghrelin Concentration (pg/mL)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
|
Baseline and 6 months after surgery
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Change in Daily Carbohydrate Intake (g/day)
時間枠：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.
|
Baseline and 6 months after surgery
|
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Change in Daily Fat Intake (g/day)
時間枠：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.
|
Baseline and 6 months after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Body Weight (kg)
時間枠：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)
時間枠：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)
時間枠：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
|
|
Change in Hip Circumference (cm)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Özlem ÖZPAK AKKUŞ, Assoc. Prof.、Toros University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年2月1日
試験登録日
最初に提出
2026年5月20日
QC基準を満たした最初の提出物
2026年6月2日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月9日
QC基準を満たした最後の更新が送信されました
2026年6月2日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BCKLY-YDB-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Anthropometric Measurements and Dietary Assessmentの臨床試験
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Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Dartmouth-Hitchcock Medical Center; Griffin Hospital と他の協力者募集