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This study aims to evaluate the changes in metabolic parameters, intestinal permeability, and gastrointestinal symptoms in individuals who have undergone bariatric surgery (Laparoscopic Sleeve Gastrectomy - LSG) for obesity treatment.
Obesity is a chronic disease associated with serious health complications including type 2 diabetes, hypertension, cardiovascular disease, and metabolic disorders. Bariatric surgery is currently the most effective treatment method for morbid obesity. However, monitoring patients after surgery in terms of metabolic health, gut permeability, and gastrointestinal symptoms is crucial for long-term success.
In this study, 40 volunteers (aged 19-50) who have undergone LSG surgery within the last month will be followed for 6 months. At the beginning of the study and 6 months later, the following will be assessed:
The study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic. Results will contribute to understanding the relationship between bariatric surgery and gut health, potentially helping to prevent postoperative complications.
Obesity is defined by the World Health Organization (WHO) as abnormal or excessive fat accumulation that presents a risk to health. Bariatric surgery, particularly Laparoscopic Sleeve Gastrectomy (LSG), is considered the most effective long-term treatment for morbid obesity.
This prospective observational study will be conducted at Bursa Yıldırım Doruk Hospital with 40 volunteers who have undergone LSG within the last month. Participants will be evaluated at baseline (immediately after surgery) and at 6 months post-surgery.
Assessments include:
Statistical analyses will be performed using the Statistical Package for the Social Sciences (SPSS) 22.0. Normal distribution will be assessed using Kolmogorov-Smirnov/Shapiro-Wilk tests. Results will be expressed as mean ± standard deviation for continuous variables and frequency/percentage for categorical variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LSG Group | Adults aged 19-50 years who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital. Participants will be evaluated at baseline and 6 months after surgery for metabolic parameters, intestinal permeability markers, gastrointestinal symptoms, anthropometric measurements, and dietary intake. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical and Biochemical Assessment | Other | Participants will undergo two assessment visits: at baseline (within 1 month post-surgery) and at 6-month follow-up. Each visit includes anthropometric measurements (body weight, height, waist and hip circumference, BMI), biochemical blood analysis (fasting glucose, lipid profile, insulin, zonulin, secretory IgA, LPS), gastrointestinal symptom evaluation via GSRS, and 3-day dietary records. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Blood Glucose Concentration (mg/dL) | Change in serum fasting blood glucose levels after 12-hour fasting between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Total Cholesterol Concentration (mg/dL) | Change in serum total cholesterol levels after 12-hour fasting between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Triglyceride Concentration (mg/dL) | Change in serum triglyceride levels after 12-hour fasting between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in HDL Cholesterol Concentration (mg/dL) | Change in serum high-density lipoprotein (HDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in LDL Cholesterol Concentration (mg/dL) | Change in serum low-density lipoprotein (LDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in VLDL Cholesterol Concentration (mg/dL) | Change in serum very low-density lipoprotein (VLDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Fasting Insulin Concentration (µIU/mL) | Change in serum fasting insulin levels after 12-hour fasting between baseline and 6-month follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight (kg) | Change in body weight between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Body Mass Index (kg/m²) | 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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Inclusion Criteria:
Exclusion Criteria:
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Adults with morbid obesity who underwent Laparoscopic Sleeve Gastrectomy (LSG) at Bursa Yıldırım Doruk Hospital General Surgery Clinic within the last month, meeting the inclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Betül GÜLŞEN, Assoc. Prof. | Contact | +903246253300 | betul.atalay@toros.edu.tr | |
| Özlem ÖZPAK AKKUŞ, Assoc. Prof. | Contact | +903246253300 | dytozlemozpak@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Betül GÜLŞEN, Assoc. Prof. | Toros University | Principal Investigator |
| Özlem ÖZPAK AKKUŞ, Assoc. Prof. | Toros University | Study Chair |
| Doğukan DURAK, Assoc. Prof. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa Yıldırım Doruk Hospital | Bursa | Bursa | 16310 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9481153 | Background | Revicki DA, Wood M, Wiklund I, Crawley J. Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease. Qual Life Res. 1998 Jan;7(1):75-83. doi: 10.1023/a:1008841022998. | |
| 31197613 | Background | Debedat J, Clement K, Aron-Wisnewsky J. Gut Microbiota Dysbiosis in Human Obesity: Impact of Bariatric Surgery. Curr Obes Rep. 2019 Sep;8(3):229-242. doi: 10.1007/s13679-019-00351-3. |
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Individual participant data will not be shared due to ethical considerations and participant confidentiality. Data will be stored securely and used only for the purposes of this study in accordance with Turkish Personal Data Protection Law (KVKK) and the ethical approval pending from Toros University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee.
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|
|
| Baseline and 6 months |
| Change in Serum Zonulin Concentration (ng/mL) | Change in serum zonulin levels assessed by ELISA method between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Serum Secretory IgA Concentration (mg/dL) | Change in serum secretory IgA levels assessed by ELISA method between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Serum LPS Concentration (EU/mL) | Change in serum lipopolysaccharide (LPS) levels assessed by ELISA method between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score (1-7) | Change in total score of the Gastrointestinal Symptom Rating Scale (GSRS) between baseline and 6-month follow-up. The scale consists of 15 items across 5 subscales; scores range from 1 to 7, with higher scores indicating more severe gastrointestinal symptoms. | Baseline and 6 months |
| Baseline and 6 months |
| Change in Waist Circumference (cm) | Change in waist circumference between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Hip Circumference (cm) | Change in hip circumference between baseline and 6-month follow-up. | Baseline and 6 months |
| Change in Waist-to-Hip Ratio | 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 |
| Change in Daily Energy Intake (kcal/day) | Change in daily energy intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software. | Baseline and 6 months |
| Change in Daily Protein Intake (g/day) | Change in daily protein intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software. | Baseline and 6 months |
| Change in Daily Carbohydrate Intake (g/day) | Change in daily carbohydrate intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software. | Baseline and 6 months |
| Change in Daily Fat Intake (g/day) | Change in daily fat intake assessed by 3-day dietary intake records between baseline and 6-month follow-up. Data will be analyzed using BeBIS 8.2 software. | Baseline and 6 months |
| Bursa Yıldırım Doruk Hospital, General Surgery Clinic |
| Study Director |
| 24388028 | Background | Khanna S, Tosh PK. A clinician's primer on the role of the microbiome in human health and disease. Mayo Clin Proc. 2014 Jan;89(1):107-14. doi: 10.1016/j.mayocp.2013.10.011. |
| 28579205 | Background | Kalarchian MA, King WC, Devlin MJ, White GE, Marcus MD, Garcia L, Yanovski SZ, Mitchell JE. Surgery-related gastrointestinal symptoms in a prospective study of bariatric surgery patients: 3-year follow-up. Surg Obes Relat Dis. 2017 Sep;13(9):1562-1571. doi: 10.1016/j.soard.2017.03.028. Epub 2017 Apr 4. |
| 16417752 | Background | Poves I, Cabrera M, Maristany C, Coma A, Ballesta-Lopez C. Gastrointestinal quality of life after laparoscopic Roux-en-Y gastric bypass. Obes Surg. 2006 Jan;16(1):19-23. doi: 10.1381/096089206775222032. |
| 17356530 | Background | Karlsson J, Taft C, Ryden A, Sjostrom L, Sullivan M. Ten-year trends in health-related quality of life after surgical and conventional treatment for severe obesity: the SOS intervention study. Int J Obes (Lond). 2007 Aug;31(8):1248-61. doi: 10.1038/sj.ijo.0803573. Epub 2007 Mar 13. |
| 15479938 | Background | Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724. |
| 28134719 | Background | Turan N, Ast TA, Kaya N. Reliability and Validity of the Turkish Version of the Gastrointestinal Symptom Rating Scale. Gastroenterol Nurs. 2017 Jan/Feb;40(1):47-55. doi: 10.1097/SGA.0000000000000177. |
| Background | Pekcan G, Şanlıer N, Baş M, Acar Tek N, Gökmen Özel H. Türkiye Beslenme Rehberi (TÜBER) 2022. Ankara: Hazar Reklamcılık; 2022. |
| Background | Beslenme Bilgi Sistemleri Paket Programı (BeBIS 8.2). İstanbul: Software NDB; 2015. |
| Background | Merdol TK. Toplu Beslenme Yapılan Kurumlar için Standart Yemek Tarifleri. Hatipoğlu Yayınları; 2003. |
| Background | Rakıcıoğlu N, Tek NA, Ayaz A, Pekcan G. Yemek ve Besin Fotoğraf Kataloğu Ölçü ve Miktarlar. Nadir Kitap; 2012. |
| 8594834 | 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. |
| Background | Pekcan G. Beslenme durumunun saptanması. Diyet El Kitabı. Ankara: Hatipoğlu Yayınevi; 2013:67-142. |
| Background | Kuyucu A. Bariatrik cerrahi uygulanmış hastaların ameliyat sonrası altı ay ve üzeri sürede vücut ağırlığı kaybının, besin tüketim durumunun ve bazı biyokimyasal bulgularının belirlenmesi. Yüksek Lisans Tezi. Gaziantep: Hasan Kalyoncu Üniversitesi Sağlık Bilimleri Enstitüsü; 2018. |
| 23656715 | Background | Hornig M. The role of microbes and autoimmunity in the pathogenesis of neuropsychiatric illness. Curr Opin Rheumatol. 2013 Jul;25(4):488-795. doi: 10.1097/BOR.0b013e32836208de. |
| 24956966 | Background | Borre YE, O'Keeffe GW, Clarke G, Stanton C, Dinan TG, Cryan JF. Microbiota and neurodevelopmental windows: implications for brain disorders. Trends Mol Med. 2014 Sep;20(9):509-18. doi: 10.1016/j.molmed.2014.05.002. Epub 2014 Jun 20. |
| 22234378 | Background | Davey KJ, O'Mahony SM, Schellekens H, O'Sullivan O, Bienenstock J, Cotter PD, Dinan TG, Cryan JF. Gender-dependent consequences of chronic olanzapine in the rat: effects on body weight, inflammatory, metabolic and microbiota parameters. Psychopharmacology (Berl). 2012 May;221(1):155-69. doi: 10.1007/s00213-011-2555-2. Epub 2012 Jan 11. |
| 26499352 | Background | Chen JC, Lee WJ, Tsou JJ, Liu TP, Tsai PL. Effect of probiotics on postoperative quality of gastric bypass surgeries: a prospective randomized trial. Surg Obes Relat Dis. 2016 Jan;12(1):57-61. doi: 10.1016/j.soard.2015.07.010. Epub 2015 Jul 18. |
| 26227517 | Background | Neil JA, Roberson DW. Enhancing nursing care by understanding the bariatric patient's journey. AORN J. 2015 Aug;102(2):132-40. doi: 10.1016/j.aorn.2015.05.014. |
| 27046364 | Background | King WC, Chen JY, Belle SH, Courcoulas AP, Dakin GF, Elder KA, Flum DR, Hinojosa MW, Mitchell JE, Pories WJ, Wolfe BM, Yanovski SZ. Change in Pain and Physical Function Following Bariatric Surgery for Severe Obesity. JAMA. 2016 Apr 5;315(13):1362-71. doi: 10.1001/jama.2016.3010. |
| 17128540 | Background | Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. doi: 10.3949/ccjm.73.11.993. |
| 15802071 | Background | Poole NA, Al Atar A, Kuhanendran D, Bidlake L, Fiennes A, McCluskey S, Nussey S, Bano G, Morgan JF. Compliance with surgical after-care following bariatric surgery for morbid obesity: a retrospective study. Obes Surg. 2005 Feb;15(2):261-5. doi: 10.1381/0960892053268499. |
| Background | Usta E, Çavdar İ. Obezite cerrahisinde hemşirelik bakımı. Cumhuriyet Hemşirelik Dergisi 2013;2(2):71-77. |
| 11054242 | Background | Monteforte MJ, Turkelson CM. Bariatric surgery for morbid obesity. Obes Surg. 2000 Oct;10(5):391-401. doi: 10.1381/096089200321594246. |
| Background | Satman İ. Türkiye'de obezite sorunu. Türkiye Klinikleri Gastroenterohepatoloji Dergisi 2016;9(2):1-11. |
| Background | Altunkaynak B, Özbek E. Obezite: Nedenleri ve tedavi seçenekleri. Dicle Tıp Dergisi 2007;34(2):144-149. |
| 26894909 | Background | Afshar S, Kelly SB, Seymour K, Woodcock S, Werner AD, Mathers JC. The Effects of Bariatric Procedures on Bowel Habit. Obes Surg. 2016 Oct;26(10):2348-54. doi: 10.1007/s11695-016-2100-9. |
| 27340299 | Background | Nuttall FQ. Body Mass Index: Obesity, BMI, and Health: A Critical Review. Nutr Today. 2015 May;50(3):117-128. doi: 10.1097/NT.0000000000000092. Epub 2015 Apr 7. |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D015930 | Diet Records |
| ID | Term |
|---|---|
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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