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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Odense University Hospital | OTHER |
| Esbjerg University Hospital of South-West Jutland | UNKNOWN |
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Prospective non-randomized intervention case control study on patients with a BMI > 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation). |
|
| Control | No Intervention | Age, BMI and co-morbidity matched group who do not undergo surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Roux en y gastric bypass or gastric sleeve operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who will die during the follow up period in case and control group | Difference in mortality between cases and controls with various NAFLD severity on biopsy. | 10 years follow up after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participant who will experience progressive fatty liver disease in case and control group | Difference NAFLD severity between case and control group after 10 years follow up. Simple steatosis is the mildest form and liver cirrhosis is the most serious manifestation:
|
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Inclusion Criteria case group:
Inclusion criteria control group:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mette M Lauridsen, MD PhD | Contact | 4579182000 | mette.enok.munk.lauridsen@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Mette M Lauridsen, MD, PhD | Esbjerg Hospital - University Hospital of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Southwest Jutland | Recruiting | Esbjerg | 6700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40677693 | Derived | Wernberg CW, Indira Chandran V, Lauridsen MM, Skytthe MK, Hansen CD, Hansen JK, Gronkjaer LL, Jacobsen BG, Di Caterino T, Detlefsen S, Thiele M, Guiliani AM, Villesen IF, Leeming DJ, Karsdal M, Graversen JH, Krag A. Ability of soluble TREM2 and PRO-C3 as biomarkers to predict changes in MASLD activity. JHEP Rep. 2025 Apr 22;7(8):101432. doi: 10.1016/j.jhepr.2025.101432. eCollection 2025 Aug. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D001928 | Brain Diseases, Metabolic |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 10 years follow up after inclusion |
| Change in continuous reaction time measurement after bariatric surgery | Continuous reaction time measurement will measure reaction time instability and is a measure of metabolic encephalopathy. The method is a 10-minutes, computerised registration of a series of motor reaction times to an auditory stimulus, with results reported as the CRTindex (50 percentile/(90-10) percentile) as a parameter of reaction time variability. A CRT index below 1.9 i considerede abnormal a may be a sign of hepatic encephalopathy. | 10 years follow up after inclusion |
| Change in EEG after bariatric surgery | Change in mean dominant frequency(MD) on EEG spectral analysis. EEG disturbances in hepatic encephalopathy are (rated by severity)but there is no enough space here to describe it. | 24 months after surgery |
| Change in intelligence quotient after bariatric surgery | Measured by Weschlers adult intelligence scale (WAIS). An IQ if 100 i the norm. Range 50-150. | 24 months efter surgery |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |