Liver Transplantation, Obesity
Conditions
Keywords
Obesity, Liver transplantation, weight loss diet, immunosuppression
Brief summary
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.
Detailed description
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.
Interventions
OTHERWeight loss diet
Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Minas Gerais
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* CONTROL GROUP: Women/men aged 18-60 years old; Body mass index 25-40 kg/m2. * IMMUNOSSUPPRESSED PATIENTS: Women/men aged 18-60 years old; Body mass index 25-40 kg/m2; liver transplantation between 1-3 years from the time of recruitment.
Exclusion criteria
* CONTROL GROUP: Pregnant or lactating womenbuse of alcohol or drugs * Endocrine disease * Use of hormones which interferes in the weight * Use of insulin or anti-inflammatory, and antidepressants drugs * Use of drugs to loss weight * Immunosuppressed patients * Subjects in another weight loss program * Subjects submitted to bariatric surgery * IMMUNOSSUPPRESSED PATIENTS: Pregnant or lactating women * Abuse of alcohol or drugs * Endocrine disease * Use of hormones which interferes in the weight * Use of insulin or antidepressants drugs * Use of drugs to loss weight * Subjects in another weight loss program * Subjects submitted to bariatric surgery, re-transplanted patients, hepatic insufficiency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight measurement from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | The weight loss will be measured by weighing volunteers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in basal metabolic rate from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Basal metabolic rate will be measured by calorimetry. |
| Change in inflammatory mediators serum levels from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | 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. |
| Change in depressive symptoms from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory. |
| Change in anxiety symptoms from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory. |
| Change in quality of life from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Nutritional effect in quality of life will be measured by Medical Outcomes Study 36 - Item Short - Form Health Survey. |
| Change in perceived stress from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Nutritional effect in perceived stress will be measured by the Perceived Stress Scale. |
| Change in body composition from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | The effect of the weight loss diet in body composition will be measured by bioimpedance. |
| Changes in serum levels of neurotrophic factors from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Nutritional effect in the serum levels of brain-derived neurotrophic factor, glial-derived neurotrophic factor and neurotrophin-3 and neurotrophin 4/5. |
| Change in metabolic markers serum levels from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Nutritional effect in the levels of triglycerides, cholesterol and glucose |
| Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Analysis of cytokines in the sera of immunosupressed patients. |
| Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up.. | Baseline and 30, 60, 90 and 180 days | Analysis of cytokines in cell culture (PBMC) of immunosupressed patients. |
| Characterization of the immunological profile of liver transplanted patients in the baseline. | Baseline. | The cells will be immuno-phenotyped for the ex vivo condition and also submitted to culture in the presence of different stimuli. |
| Change in quality of diet from baseline until 6 months follow up. | Baseline and 30, 60, 90 and 180 days | Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10. |
Countries
Brazil
Outcome results
None listed