NCT03103984

Immunosuppression and Diet: the Role of Inflammation in the Adipose Tissue Remodeling

Immunosuppression and Diet: the Role of Inflammation in the Adipose Tissue Remodeling After Liver Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Liver Transplantation

Interventions

Type	Name	Description
OTHER	Weight loss diet	Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2017-04-07
• Last updated: 2018-06-26

Locations

1 site across 1 country: Brazil