Clinical trial NCT03103984: Immunosuppression and Diet: the Role of Inflammation in the Adipose Tissue Remodeling
Official title: Immunosuppression and Diet: the Role of Inflammation in the Adipose Tissue Remodeling After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Liver Transplantation
Keywords: Obesity
Liver transplantation
weight loss diet
immunosuppression
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2017-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in weight measurement from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
Secondary outcomes:
measure: Change in body composition from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Change in basal metabolic rate from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Change in inflammatory mediators serum levels from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Change in depressive symptoms from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Change in anxiety symptoms from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Change in quality of life from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Change in perceived stress from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Change in quality of diet from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Changes in serum levels of neurotrophic factors from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Change in metabolic markers serum levels from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up.
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up..
timeFrame: Baseline and 30, 60, 90 and 180 days
measure: Characterization of the immunological profile of liver transplanted patients in the baseline.
timeFrame: Baseline.
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital da Clínicas da UFMG
state: MG
Study officials:
affiliation: UFMG
name: Débora Fernandes Rodrigues, Master
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.