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

Federal University of Minas Gerais

Status: Completed

Conditions: Liver Transplantation; Obesity

Treatments: Other: Weight loss diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03103984

30409114.8.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

Experimental group

Description:

The volunteers (overweight and obese) will receive nutritional counseling and a weight loss diet.

Treatment:

Other: Weight loss diet

Immunosuppressed patients

Experimental group

Description:

The volunteers (liver transplantation) will receive nutritional counseling and a weight loss diet.

Treatment:

Other: Weight loss diet