Evaluation of Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms After Bariatric Surgery in Body Weight Management

NCT07643376 — Not yet recruiting, 40 participants, Toros University
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Evaluation of Postoperative Metabolic Parameters, Intestinal Permeability and Gastrointestinal Symptoms in Body Weight Management After Laparoscopic Sleeve Gastrectomy

RegistryNCT07643376, acronym METABAR
StatusNot yet recruiting
Study typeObservational
Enrollment40 (Estimated)
SponsorToros University (Other)
ConditionsObesity, Morbid, Bariatric Surgery, Intestinal Permeability, Gastrointestinal Symptoms, Metabolic Syndrome
InterventionsClinical and Biochemical Assessment (Other)
Datesstart 2026-07-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-06-11, last updated 2026-06-11
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity, Morbid All trials for Bariatric Surgery All trials of Clinical and Biochemical Assessment

-Summary

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:

* Metabolic parameters: fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels
* Intestinal permeability markers: zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels
* Gastrointestinal symptoms: assessed using the Gastrointestinal Symptom Rating Scale (GSRS)
* Anthropometric measurements: body weight, height, waist and hip circumference, BMI
* Nutritional intake: 3-day dietary records

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.

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+Detailed description

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:

1. Anthropometric Measurements: Body weight, height, waist and hip circumference will be measured. BMI and waist-to-hip ratio will be calculated according to WHO criteria.
2. Biochemical Parameters: Fasting blood glucose, total cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) cholesterol, and insulin levels will be obtained from patient records. Zonulin, secretory immunoglobulin A (IgA), and lipopolysaccharide (LPS) levels will be analyzed using ELISA method (Biotek TS800) with commercial kits (RelAssay® Diagnostics, Ankara, Turkey) at Ankara Diagen Laboratory. Samples will be stored at -20°C until analysis.
3. Gastrointestinal Symptom Rating Scale (GSRS): A validated 15-item scale assessing five dimensions: diarrhea, indigestion, constipation, abdominal pain, and reflux. Scores range from 1 (no discomfort) to 7 (very severe discomfort). Turkish validity and reliability was established by Turan and Asti (2011).
4. Dietary Assessment: 3-day dietary records will be collected and analyzed using the Nutrition Information System (BeBIS) 8.2 software. Results will be evaluated according to the Turkish Dietary Guidelines 2022 (TUBER 2022).

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.

+Arms and interventions

ArmTypeInterventionsDescription
LSG GroupOther: Clinical and Biochemical AssessmentAdults 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.
  • Clinical and Biochemical Assessment (Other), also known as Anthropometric Measurement, Biochemical Blood Analysis, Gastrointestinal Symptom Rating Scale (GSRS), 3-Day Dietary Record, Intestinal Permeability Assessment: 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.

+Outcome measures

Primary outcomes

  • Change in Fasting Blood Glucose Concentration (mg/dL) [Baseline and 6 months]: Change in serum fasting blood glucose levels after 12-hour fasting between baseline and 6-month follow-up.
  • Change in Total Cholesterol Concentration (mg/dL) [Baseline and 6 months]: Change in serum total cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
  • Change in Triglyceride Concentration (mg/dL) [Baseline and 6 months]: Change in serum triglyceride levels after 12-hour fasting between baseline and 6-month follow-up.
  • Change in HDL Cholesterol Concentration (mg/dL) [Baseline and 6 months]: Change in serum high-density lipoprotein (HDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
  • Change in LDL Cholesterol Concentration (mg/dL) [Baseline and 6 months]: Change in serum low-density lipoprotein (LDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
  • Change in VLDL Cholesterol Concentration (mg/dL) [Baseline and 6 months]: Change in serum very low-density lipoprotein (VLDL) cholesterol levels after 12-hour fasting between baseline and 6-month follow-up.
  • Change in Fasting Insulin Concentration (µIU/mL) [Baseline and 6 months]: Change in serum fasting insulin levels after 12-hour fasting between baseline and 6-month follow-up.
  • Change in Serum Zonulin Concentration (ng/mL) [Baseline and 6 months]: Change in serum zonulin levels assessed by ELISA method between baseline and 6-month follow-up.
  • Change in Serum Secretory IgA Concentration (mg/dL) [Baseline and 6 months]: Change in serum secretory IgA levels assessed by ELISA method between baseline and 6-month follow-up.
  • Change in Serum LPS Concentration (EU/mL) [Baseline and 6 months]: Change in serum lipopolysaccharide (LPS) levels assessed by ELISA method between baseline and 6-month follow-up.
  • Change in Gastrointestinal Symptom Rating Scale (GSRS) Total Score (1-7) [Baseline and 6 months]: 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.

Secondary outcomes

  • Change in Body Weight (kg) [Baseline and 6 months]: Change in body weight between baseline and 6-month follow-up.
  • Change in Body Mass Index (kg/m²) [Baseline and 6 months]: Change in BMI between baseline and 6-month follow-up. Weight and height will be combined to report BMI in kg/m².
  • Change in Waist Circumference (cm) [Baseline and 6 months]: Change in waist circumference between baseline and 6-month follow-up.
  • Change in Hip Circumference (cm) [Baseline and 6 months]: Change in hip circumference between baseline and 6-month follow-up.
  • Change in Waist-to-Hip Ratio [Baseline and 6 months]: 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.
  • Change in Daily Energy Intake (kcal/day) [Baseline and 6 months]: 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.
  • Change in Daily Protein Intake (g/day) [Baseline and 6 months]: 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.
  • Change in Daily Carbohydrate Intake (g/day) [Baseline and 6 months]: 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.
  • Change in Daily Fat Intake (g/day) [Baseline and 6 months]: 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.

+Eligibility

Sex: All, ages: 19 Years to 50 Years

Inclusion Criteria:

* Underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last 1 month
* Aged between 19-50 years
* BMI ≥40 kg/m² or BMI ≥35 kg/m² with obesity-related comorbidities
* Signed informed consent form
* Non-smoker and non-alcohol dependent

Exclusion Criteria:

* Did not undergo or is not planned to undergo LSG
* Outside the age range of 19-50 years
* Did not sign the informed consent form
* BMI <40 kg/m² or BMI <35 kg/m² without obesity-related comorbidities
* Smoker or alcohol dependent
* Has an inflammatory disease
* Currently using probiotics, antibiotics, or fiber supplements
* Has a psychiatric disorder

+Locations (1)

FacilityCityCountryStatus
Bursa Yıldırım Doruk HospitalBursa, BursaTurkey (Türkiye)

+Publications

  • 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. PMID 9481153
  • 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. PMID 31197613
  • 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. PMID 24388028
  • 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. PMID 28579205
  • 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. PMID 16417752
  • 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. PMID 17356530
  • 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. PMID 15479938
  • 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. PMID 28134719
  • Pekcan G, Şanlıer N, Baş M, Acar Tek N, Gökmen Özel H. Türkiye Beslenme Rehberi (TÜBER) 2022. Ankara: Hazar Reklamcılık; 2022.
  • Beslenme Bilgi Sistemleri Paket Programı (BeBIS 8.2). İstanbul: Software NDB; 2015.
  • Merdol TK. Toplu Beslenme Yapılan Kurumlar için Standart Yemek Tarifleri. Hatipoğlu Yayınları; 2003.
  • Rakıcıoğlu N, Tek NA, Ayaz A, Pekcan G. Yemek ve Besin Fotoğraf Kataloğu Ölçü ve Miktarlar. Nadir Kitap; 2012.
  • 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 8594834
  • Pekcan G. Beslenme durumunun saptanması. Diyet El Kitabı. Ankara: Hatipoğlu Yayınevi; 2013:67-142.
  • 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.
  • 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. PMID 23656715
  • 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. PMID 24956966
  • 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. PMID 22234378
  • 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. PMID 26499352
  • 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. PMID 26227517
  • 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. PMID 27046364
  • 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. PMID 17128540
  • 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. PMID 15802071
  • Usta E, Çavdar İ. Obezite cerrahisinde hemşirelik bakımı. Cumhuriyet Hemşirelik Dergisi 2013;2(2):71-77.
  • Monteforte MJ, Turkelson CM. Bariatric surgery for morbid obesity. Obes Surg. 2000 Oct;10(5):391-401. doi: 10.1381/096089200321594246. PMID 11054242
  • Satman İ. Türkiye'de obezite sorunu. Türkiye Klinikleri Gastroenterohepatoloji Dergisi 2016;9(2):1-11.
  • Altunkaynak B, Özbek E. Obezite: Nedenleri ve tedavi seçenekleri. Dicle Tıp Dergisi 2007;34(2):144-149.
  • 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. PMID 26894909
  • 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. PMID 27340299

+Investigators

  • Betül GÜLŞEN, Assoc. Prof., Principal investigator, Toros University
  • Özlem ÖZPAK AKKUŞ, Assoc. Prof., Study chair, Toros University
  • Doğukan DURAK, Assoc. Prof., Study director, Bursa Yıldırım Doruk Hospital, General Surgery Clinic