Sympatomatic cholecystolithiasis, gallstone disease
Conditions
Interventions
At four pre-specified intervals (baseline, after 3 months, 1 year, and 2 
years), all enrolled patients will be administered a standardized fat load 
(whipped cream), followed by systematic collection of postprandial blood 
samples. Furthermore, patients will complete lifestyle questionnaires, undergo 
basic physical examinations (including measurements of weight, height, and 
waist circumference), a ultrasound imaging and fibroscan of the 
liver will be conducted to determine liver steatosis, and faecal samples will 
be collected.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients referred to a surgeon with abdominal complaints and ultrasound proven gallstones or sludge (proven before or after referral) subjected to a laparoscopic cholecystectomy or conservative treatment • Availability of informed consent. • Age 30-60 years
Exclusion criteria
Exclusion criteria: Patients with pre-operative signs of complicated gallstone disease (cholecystitis, choledocholithiasis, cholangitis, pancreatitis), Signs of cholestasis requiring intervention (Endoscopic Retrograde Cholangio- and Pancreatography) Metabolic syndrome at baseline according to the criteria listed in 8.1.2. (39)Family history of diabetes mellitus (type I or II)Insulin resistance at baseline measured by the QUICKI index (Quantitative Insulin-sensitivity Check Index). Insulin resistance is defined as a QUICKI score = 0.339 (1, 2)HbA1c outside normal range (> 39 mmol/mol), values above 39 mmol/mol indicate prediabetes (1)ASA score III (patient with severe systemic disease (e.g., morbid obesity, renal failure) or IV (patient with severe systemic disease that is a constant threat to life)Malignancy (excluding skin malignancies: basal cell carcinoma and non-metastatic squamous cell carcinoma)History after bariatric surgery or expected bariatric procedure within 2 years.History of inflammatory bowel disease.History of alcohol abuse (man >3 and women >2 glasses per day)Liver disease (i.e. (autoimmune hepatitis) Use steatogenic medication (i.e., methotrexate, tamoxifen, amiodarone, and systemic corticosteroids) Use of DPP4-inhibitors or GLP-1 receptor agonists (e.g. Semaglutide)Diabetes mellitusUse of antibiotics in the previous 3 months Gastro-intestinal surgery in the previous 3 monthsStoma (small bowel or colon)Patients that are lactose intolerant / allergic to dairyKnown anaemia < 6 mmol/lExpected short life span of less than 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is changes in serum Fibroblast Growth Factor 19 (FGF-19) concentration in response to a standardized fat load. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are: 1) changes in hepatic steatosis (MASLD) (assessed by ultrasound imaging of the liver and fibroscan); 2) changes in incidence of metabolic syndrome (waist circumference, BMI, blood pressure, glucose intolerance/insulin resistance (glucose tolerance test)); 3) changes in post-prandial bile-salt excursion; 4) changes in incretin response (GLP-1, GIP); 5) changes in lipid spectrum (TC, triglyceride, LDL, HDL, VLDL); 6) changes in glucose tolerance; 7) changes in faecal microbial composition. | — |
Countries
Netherlands
Contacts
Public ContactS Bluiminck
Radboud Universitair Medisch Centrum
Outcome results
None listed