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The goal of this clinical trial is to improve the treatment of hepatic steatosis associated with obesity with pharmacological and nutritionnal approaches. The main question it aims to answer is:
Does an individualized nutritionnal approach with a dietician combined with medication targeting obesity is the most efficient way to treat hepatic steatosis associated with obesity?
Participants will either participate in one of three groups:
Participants in each group will be followed during a year for 4 timepoints (0, 3, 6 and 12 months). Blood and feces samples, anthropometric measures, transient elastography measurements and health questionnaires will be assessed at each timepoint.
The nutritionnal intervention targeting hepatic steastosis associated with obesity will use conclusions from a systematic review we conducted on nutritionnal approaches to treat liver steatosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition | Active Comparator | This arm will only participate in an individualized nutritionnal approach. |
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| Nutrition + Semaglutide | Active Comparator | This arm will initiate a pharmacological intervention to treat obesity (Semaglutide) and will participate in an individualized nutritionnal approach. |
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| Semaglutide | Active Comparator | This arm will only initiate a pharmacological intervention to treat obesity (Semaglutide) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Participants receiving this intervention will be starting with a dose of semaglutide 0.25 mg. Physicians will follow Wegovy® Dosing Schedule guidelines, ending with a final dose of 2.4 mg at the fifth month. Type 2 diabetes participants wishing to stop at 1.0 mg will be allowed. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Steatosis | Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic steatosis based on CAP (dB/m) (specific to FibroScan®): S0 (< 302), S1 (302-331), S2 (331-337) and S3 (>337). | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Liver Stiffness | Transient elastography is an ultrasound-based modality that is non-invasive and measures the degree of steatosis with the controlled attenuation parameter (CAP; dB/m) and liver stiffness (kPa).This method will be used at each visit to follow the progression and the efficiency of the interventions. The following ranges will be use to classify hepatic fibrosis based on liver stiffness (kPa) (specific to FibroScan®): F0-F1 (< 8.0), F2 (8.9-9.7), F3 (9.7-13.6) and F4 (>13.6). | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function (biochemistry) | Blood samples will be drawn at each visit to assess the following measures: liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT], alkaline phosphatase [ALP]), total bilirubin and albumin. Liver scores will also be calculated: fatty liver index (FLI) and fibrosis-4 index (FIB-4) The following normal ranges will be used:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tristan Rocheleau, RD., M.Sc. | Contact | 418-656-8711, #2681 | tristan.rocheleau.2@ulaval.ca | |
| Fannie Lajeunesse-Trempe, MD., Ph.D. | Contact | 418-656-8711, #8052 | fanny.lajeunesse-trempe.1@ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Fannie Lajeunesse-Trempe, MD., Ph.D. | Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Québec | Quebec | G1V 4G5 | Canada |
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| Diet | Other | Participants receiving this intervention will be seeing a registered dietician at each visit. The individualized approach will be based on recent literature (mostly hypocaloric) by using different methods. |
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| From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Lipid panel | Blood samples will be drawn at each visit to assess the lipid panel. The following ranges will be used:
| From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Change from Baseline in the gut microbiota diversity | The composition of the gut microbiota will be measured at each visit with the participants' stool samples. The difference between the concentration of gut microbiota diversity (bacteria, families, phyllum, etc.) will be analyzed. | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Change from Baseline in blood lipids and metabolites | We will perform lipidomic and metabolomic measures with blood samples of each visit with liquid chromatography coupled with mass spectrometry (LC-MS/MS). | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Glucose | Blood samples will be drawn at each visit to assess the glucose. The following range will be used: - glucose: < 5.6 mmol/L; | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Insulin | Blood samples will be drawn at each visit to assess insulin The following range will be used: - insuline: [20-60] pmol/L; | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Glycated hemoglobin | Blood samples will be drawn at each visit to assess HbA1c The following range will be used: - HbA1c: < 6.5 %; | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| C-reactive protein | Blood samples will be drawn at each visit to assess the c-reactive protein The following range will be used: - CRP: < 10 mg/L. | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Liver enzymes | Blood samples will be drawn at each visit to assess the following measures: liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transferase [GGT] and alkaline phosphatase [ALP]), The following normal ranges will be used:
| From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Fatty liver index (FLI) | The Fatty liver index (FLI) is a non-invasive score to calculate liver steatosis (using BMI, WC, TG and GGT). The following ranges will be used:
| From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| Fibrosis-4 index (FIB-4) | The fibrosis-4 index (FIB-4) is a non-invasive score to calculate liver fibrosis (using Age, AST, ALT and Platelet count). The following normal range will be used: - <30 : Low risk of hepatic steatosis ; >60 : High risk of hepatic steatosis. fatty liver index (FLI) and The following range will be used: - FIB-4 : >3.48 : High risk of cirrhosis | From enrollment to the end of the clinical trial at 12 months (for 4 visits) |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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