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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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

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Obesity Liver Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type EXPERIMENTAL

Weight loss diet

Intervention Type OTHER

Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.

Immunosuppressed patients

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

Group Type EXPERIMENTAL

Weight loss diet

Intervention Type OTHER

Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.

Interventions

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Weight loss diet

Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No