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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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The main goal of this project is to evaluate the effect of immunosuppression in the weight loss and in the metabolic status of patients after liver transplantation. It is also the purpose of this project to investigate why patients become overweight and obese after liver transplantation.
Overweight and obese post-liver transplantation patients will receive a diet to promote weight loss during 6 months. The control group (overweight and obese subjects) will be submitted to the same protocol:
The participants will be interviewed at baseline and after 30, 60, 90 and 180 days from baseline. The following measures will be assessed: body composition (fat body% and free fat body%), anthropometric measures (height, weight, body mass index, waist circumference and abdominal circumference), blood pressure, basal metabolic rate, behavioral symptoms and peripheral biomarkers in the serum. Behavioral symptoms will be assessed using the following self-reported questionnaires: Beck Depression Inventory (depression symptoms), Beck Anxiety Inventory (anxiety symptoms), Medical Outcomes Study 36 - Item Short - Form Health Survey (quality of life) and Perceived Stress Scale (stress).
Enrolled participants will receive a restrictive diet calculated based on individual requirements aiming the loss of around 5%-10% of weight/ 6 months of intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | The volunteers (overweight and obese) will receive nutritional counseling and a weight loss diet. |
|
| Immunosuppressed patients | Experimental | The volunteers (liver transplantation) will receive nutritional counseling and a weight loss diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss diet | Other | Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight measurement from baseline until 6 months follow up. | The weight loss will be measured by weighing volunteers | Baseline and 30, 60, 90 and 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition from baseline until 6 months follow up. | The effect of the weight loss diet in body composition will be measured by bioimpedance. | Baseline and 30, 60, 90 and 180 days |
| Change in basal metabolic rate from baseline until 6 months follow up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Débora Fernandes Rodrigues, Master | UFMG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da ClÃnicas da UFMG | Belo Horizonte | Minas Gerais | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11448577 | Background | Richardson RA, Garden OJ, Davidson HI. Reduction in energy expenditure after liver transplantation. Nutrition. 2001 Jul-Aug;17(7-8):585-9. doi: 10.1016/s0899-9007(01)00571-8. | |
| 26717257 | Background | Terjimanian MN, Harbaugh CM, Hussain A, Olugbade KO Jr, Waits SA, Wang SC, Sonnenday CJ, Englesbe MJ. Abdominal adiposity, body composition and survival after liver transplantation. Clin Transplant. 2016 Mar;30(3):289-94. doi: 10.1111/ctr.12688. Epub 2016 Feb 13. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004038 | Diet, Reducing |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Basal metabolic rate will be measured by calorimetry. |
| Baseline and 30, 60, 90 and 180 days |
| Change in inflammatory mediators serum levels from baseline until 6 months follow up. | Nutritional effect in the levels of interleukins, such as Interleukin-1, interleukin-6 and interleukin-10, interleukin-17, tumor necrosis factor and protein C reactive. | Baseline and 30, 60, 90 and 180 days |
| Change in depressive symptoms from baseline until 6 months follow up. | Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory. | Baseline and 30, 60, 90 and 180 days |
| Change in anxiety symptoms from baseline until 6 months follow up. | Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory. | Baseline and 30, 60, 90 and 180 days |
| Change in quality of life from baseline until 6 months follow up. | Nutritional effect in quality of life will be measured by Medical Outcomes Study 36 - Item Short - Form Health Survey. | Baseline and 30, 60, 90 and 180 days |
| Change in perceived stress from baseline until 6 months follow up. | Nutritional effect in perceived stress will be measured by the Perceived Stress Scale. | Baseline and 30, 60, 90 and 180 days |
| Change in quality of diet from baseline until 6 months follow up. | Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10. | Baseline and 30, 60, 90 and 180 days |
| Changes in serum levels of neurotrophic factors from baseline until 6 months follow up. | Nutritional effect in the serum levels of brain-derived neurotrophic factor, glial-derived neurotrophic factor and neurotrophin-3 and neurotrophin 4/5. | Baseline and 30, 60, 90 and 180 days |
| Change in metabolic markers serum levels from baseline until 6 months follow up. | Nutritional effect in the levels of triglycerides, cholesterol and glucose | Baseline and 30, 60, 90 and 180 days |
| Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up. | Analysis of cytokines in the sera of immunosupressed patients. | Baseline and 30, 60, 90 and 180 days |
| Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up.. | Analysis of cytokines in cell culture (PBMC) of immunosupressed patients. | Baseline and 30, 60, 90 and 180 days |
| Characterization of the immunological profile of liver transplanted patients in the baseline. | The cells will be immuno-phenotyped for the ex vivo condition and also submitted to culture in the presence of different stimuli. | Baseline. |
| 25142246 | Background | Noceti OM, Woillard JB, Boumediene A, Esperon P, Taupin JL, Gerona S, Valverde M, Tourino C, Marquet P. Tacrolimus pharmacodynamics and pharmacogenetics along the calcineurin pathway in human lymphocytes. Clin Chem. 2014 Oct;60(10):1336-45. doi: 10.1373/clinchem.2014.223511. Epub 2014 Aug 20. |
| 24517561 | Background | Anastacio LR, Diniz KG, Ribeiro HS, Ferreira LG, Lima AS, Correia MI, Vilela EG. Prospective evaluation of metabolic syndrome and its components among long-term liver recipients. Liver Int. 2014 Aug;34(7):1094-101. doi: 10.1111/liv.12495. Epub 2014 Mar 18. |
| 39305754 | Derived | Rodrigues DF, Fagundes GBP, Monteiro BL, Monteze NM, Rodrigues AMDS, Vieira ELM, Teixeira AL, Teixeira MM, Oliveira MC, Correia MITD, Generoso SV, Ferreira AVM. Blunted inflammatory response is associated with a lower response to a weight loss dietary intervention in liver recipients. Clin Nutr. 2024 Oct;43(10):2438-2447. doi: 10.1016/j.clnu.2024.09.029. Epub 2024 Sep 17. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |