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

Primary Purpose

Obesity, Liver Transplantation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Weight loss diet
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity focused on measuring Obesity, Liver transplantation, weight loss diet, immunosuppression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital da Clínicas da UFMG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

Immunosuppressed patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in weight measurement from baseline until 6 months follow up.
The weight loss will be measured by weighing volunteers

Secondary Outcome Measures

Change in body composition from baseline until 6 months follow up.
The effect of the weight loss diet in body composition will be measured by bioimpedance.
Change in basal metabolic rate from baseline until 6 months follow up.
Basal metabolic rate will be measured by calorimetry.
Change in inflammatory mediators serum levels from baseline until 6 months follow up.
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.
Change in depressive symptoms from baseline until 6 months follow up.
Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory.
Change in anxiety symptoms from baseline until 6 months follow up.
Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory.
Change in quality of life from baseline until 6 months follow up.
Nutritional effect in quality of life will be measured by Medical Outcomes Study 36 - Item Short - Form Health Survey.
Change in perceived stress from baseline until 6 months follow up.
Nutritional effect in perceived stress will be measured by the Perceived Stress Scale.
Change in quality of diet from baseline until 6 months follow up.
Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10.
Changes in serum levels of neurotrophic factors from baseline until 6 months follow up.
Nutritional effect in the serum levels of brain-derived neurotrophic factor, glial-derived neurotrophic factor and neurotrophin-3 and neurotrophin 4/5.
Change in metabolic markers serum levels from baseline until 6 months follow up.
Nutritional effect in the levels of triglycerides, cholesterol and glucose
Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up.
Analysis of cytokines in the sera of immunosupressed patients.
Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up..
Analysis of cytokines in cell culture (PBMC) of immunosupressed patients.
Characterization of the immunological profile of liver transplanted patients in the baseline.
The cells will be immuno-phenotyped for the ex vivo condition and also submitted to culture in the presence of different stimuli.

Full Information

First Posted
March 27, 2017
Last Updated
June 22, 2018
Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT03103984
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Liver Transplantation
Keywords
Obesity, Liver transplantation, weight loss diet, immunosuppression

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
The volunteers (overweight and obese) will receive nutritional counseling and a weight loss diet.
Arm Title
Immunosuppressed patients
Arm Type
Experimental
Arm Description
The volunteers (liver transplantation) will receive nutritional counseling and a weight loss diet.
Intervention Type
Other
Intervention Name(s)
Weight loss diet
Intervention Description
Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.
Primary Outcome Measure Information:
Title
Change in weight measurement from baseline until 6 months follow up.
Description
The weight loss will be measured by weighing volunteers
Time Frame
Baseline and 30, 60, 90 and 180 days
Secondary Outcome Measure Information:
Title
Change in body composition from baseline until 6 months follow up.
Description
The effect of the weight loss diet in body composition will be measured by bioimpedance.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Change in basal metabolic rate from baseline until 6 months follow up.
Description
Basal metabolic rate will be measured by calorimetry.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Change in inflammatory mediators serum levels from baseline until 6 months follow up.
Description
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.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Change in depressive symptoms from baseline until 6 months follow up.
Description
Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Change in anxiety symptoms from baseline until 6 months follow up.
Description
Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Change in quality of life from baseline until 6 months follow up.
Description
Nutritional effect in quality of life will be measured by Medical Outcomes Study 36 - Item Short - Form Health Survey.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Change in perceived stress from baseline until 6 months follow up.
Description
Nutritional effect in perceived stress will be measured by the Perceived Stress Scale.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Change in quality of diet from baseline until 6 months follow up.
Description
Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Changes in serum levels of neurotrophic factors from baseline until 6 months follow up.
Description
Nutritional effect in the serum levels of brain-derived neurotrophic factor, glial-derived neurotrophic factor and neurotrophin-3 and neurotrophin 4/5.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Change in metabolic markers serum levels from baseline until 6 months follow up.
Description
Nutritional effect in the levels of triglycerides, cholesterol and glucose
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up.
Description
Analysis of cytokines in the sera of immunosupressed patients.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up..
Description
Analysis of cytokines in cell culture (PBMC) of immunosupressed patients.
Time Frame
Baseline and 30, 60, 90 and 180 days
Title
Characterization of the immunological profile of liver transplanted patients in the baseline.
Description
The cells will be immuno-phenotyped for the ex vivo condition and also submitted to culture in the presence of different stimuli.
Time Frame
Baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Débora Fernandes Rodrigues, Master
Organizational Affiliation
UFMG
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital da Clínicas da UFMG
City
Belo Horizonte
State/Province
MG
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11448577
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.
Results Reference
background
PubMed Identifier
26717257
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.
Results Reference
background
PubMed Identifier
25142246
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.
Results Reference
background
PubMed Identifier
24517561
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.
Results Reference
background

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

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