Metabolic Syndrome Clinical Trial
Official title:
Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome
Prospective cohort study. POPULATION: patients with gallstone disease qualified for laparoscopic cholecystectomy INTERVENTION: patients undergoing cholecystectomy for gallstones COMPARISON: gallstone disease without surgery in an observation period OUTCOME: metabolic syndrome symptoms evaluated in 3 months period The main inclusion criteria is cholelithiasis confirmed by ultrasound examination in patients between 18-75 years old. The main exclusion criteria are metabolic syndrome, diabetes, thyroid diseases, pancreatic diseases, serious abdominal surgeries in the past, pregnancy, and lactation. Participants who qualified for laparoscopic cholecystectomy in 3 months are included in the investigation group. Those not having cholecystectomy planned in the upcoming three months for any reason (no consent for surgery, long term) are included in the control group. The intervention is to assess all metabolic syndrome criteria (blood pressure, glucose tolerance, dyslipidemia, abdominal obesity) before and three months after surgery. The endpoint is to evaluate if the risk of metabolic syndrome after cholecystectomy is higher than in patients with gallstones.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | March 30, 2025 |
Est. primary completion date | March 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - cholelithiasis Exclusion Criteria: - metabolic syndrome - obesity - diabetes - thyroid disease - pancreatic disease - serious abdominal surgeries in the past - pregnancy, lactation |
Country | Name | City | State |
---|---|---|---|
Poland | Brothers Hospitallers Hospital in Cracow | Kraków | Lesser Poland |
Lead Sponsor | Collaborator |
---|---|
Brothers Hospitallers Hospital in Cracow | Jagiellonian University |
Poland,
Barrera F, Azócar L, Molina H, Schalper KA, Ocares M, Liberona J, Villarroel L, Pimentel F, Pérez-Ayuso RM, Nervi F, Groen AK, Miquel JF. Effect of cholecystectomy on bile acid synthesis and circulating levels of fibroblast growth factor 19. Ann Hepatol. 2015 Sep-Oct;14(5):710-21. — View Citation
Chen Y, Wu S, Tian Y. Cholecystectomy as a risk factor of metabolic syndrome: from epidemiologic clues to biochemical mechanisms. Lab Invest. 2018 Jan;98(1):7-14. doi: 10.1038/labinvest.2017.95. Epub 2017 Sep 11. Review. — View Citation
Di Ciaula A, Garruti G, Wang DQ, Portincasa P. Cholecystectomy and risk of metabolic syndrome. Eur J Intern Med. 2018 Jul;53:3-11. doi: 10.1016/j.ejim.2018.04.019. Epub 2018 Apr 26. Review. — View Citation
Garruti G, Wang DQ, Di Ciaula A, Portincasa P. Cholecystectomy: a way forward and back to metabolic syndrome? Lab Invest. 2018 Jan;98(1):4-6. doi: 10.1038/labinvest.2017.129. — View Citation
Latenstein CSS, Alferink LJM, Darwish Murad S, Drenth JPH, van Laarhoven CJHM, de Reuver PR. The Association Between Cholecystectomy, Metabolic Syndrome, and Nonalcoholic Fatty Liver Disease: A Population-Based Study. Clin Transl Gastroenterol. 2020 Apr;11(4):e00170. doi: 10.14309/ctg.0000000000000170. — View Citation
Qi L, Tian Y, Chen Y. Gall bladder: The metabolic orchestrator. Diabetes Metab Res Rev. 2019 Jul;35(5):e3140. doi: 10.1002/dmrr.3140. Epub 2019 Feb 27. Review. — View Citation
Tsai MS, Lin CL, Hsu YC, Lee HM, Kao CH. Long-term risk of pancreatitis and diabetes after cholecystectomy in patients with cholelithiasis but no pancreatitis history: a 13-year follow-up study. Eur J Intern Med. 2015 Sep;26(7):540-4. doi: 10.1016/j.ejim.2015.06.013. Epub 2015 Jul 2. — View Citation
Yue W, Sun X, Du T. Cholecystectomy versus central obesity or insulin resistance in relation to the risk of nonalcoholic fatty liver disease: the third US National Health and Nutrition Examination Survey. BMC Endocr Disord. 2019 Sep 2;19(1):95. doi: 10.1186/s12902-019-0423-y. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk of the metabolic syndrome in patients undergoing laparoscopic cholecystectomy | Evaluated with the rNCEP criteria for metabolic syndrome. | 3 months | |
Primary | incidence of central obesity | waist circumference in cm: men more or equal 102 cm; women more or equal 88 cm | 3 months | |
Primary | incidence of triglyceridemia | serum triglycerides level in mg/dl: more or equal 150 mg/dl | 3 months | |
Primary | incidence of dyslipidemia | serum high-density lipo-protein (HDL) level in md/dl: men less than 40 mg/dl; women less than 50 mg/dl | 3 months | |
Primary | incidence of systemic hypertension | blood preassure in mm Hg: more or equal 130 mm Hg/more or equal 85 mm Hg | 3 months | |
Primary | incidence of glucose intolerance | fasting serum glucose in mg/dl: more or equal 100 mg/dl | 3 months |
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