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

June 22, 2018 updated by: Adaliene Versiani M. Ferreira, Federal University of Minas Gerais

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil
        • Hospital da Clínicas da UFMG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control
The volunteers (overweight and obese) will receive nutritional counseling and a weight loss diet.
Other: Weight loss diet
Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.
Experimental: Immunosuppressed patients
The volunteers (liver transplantation) will receive nutritional counseling and a weight loss diet.
Other: Weight loss diet
Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in weight measurement from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
The weight loss will be measured by weighing volunteers
Baseline and 30, 60, 90 and 180 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body composition from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
The effect of the weight loss diet in body composition will be measured by bioimpedance.
Baseline and 30, 60, 90 and 180 days
Change in basal metabolic rate from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
Basal metabolic rate will be measured by calorimetry.
Baseline and 30, 60, 90 and 180 days
Change in inflammatory mediators serum levels from baseline until 6 months follow up.
Time Frame: 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.
Baseline and 30, 60, 90 and 180 days
Change in depressive symptoms from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory.
Baseline and 30, 60, 90 and 180 days
Change in anxiety symptoms from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory.
Baseline and 30, 60, 90 and 180 days
Change in quality of life from baseline until 6 months follow up.
Time Frame: 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.
Baseline and 30, 60, 90 and 180 days
Change in perceived stress from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
Nutritional effect in perceived stress will be measured by the Perceived Stress Scale.
Baseline and 30, 60, 90 and 180 days
Change in quality of diet from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10.
Baseline and 30, 60, 90 and 180 days
Changes in serum levels of neurotrophic factors from baseline until 6 months follow up.
Time Frame: 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.
Baseline and 30, 60, 90 and 180 days
Change in metabolic markers serum levels from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
Nutritional effect in the levels of triglycerides, cholesterol and glucose
Baseline and 30, 60, 90 and 180 days
Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up.
Time Frame: Baseline and 30, 60, 90 and 180 days
Analysis of cytokines in the sera of immunosupressed patients.
Baseline and 30, 60, 90 and 180 days
Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up..
Time Frame: Baseline and 30, 60, 90 and 180 days
Analysis of cytokines in cell culture (PBMC) of immunosupressed patients.
Baseline and 30, 60, 90 and 180 days
Characterization of the immunological profile of liver transplanted patients in the baseline.
Time Frame: Baseline.
The cells will be immuno-phenotyped for the ex vivo condition and also submitted to culture in the presence of different stimuli.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Minas Gerais

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Débora Fernandes Rodrigues, Master, UFMG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 30409114.8.0000.5149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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