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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103984
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Adaliene Versiani M. Ferreira, Federal University of Minas Gerais

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.

Condition or disease Intervention/treatment Phase
Obesity Liver Transplantation Other: Weight loss diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immunosuppression and Diet: the Role of Inflammation in the Adipose Tissue Remodeling After Liver Transplantation
Actual Study Start Date : July 2014
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103984


Locations
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Brazil
Hospital da Clínicas da UFMG
Belo Horizonte, MG, Brazil
Sponsors and Collaborators
Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Study Chair: Débora Fernandes Rodrigues, Master UFMG
Publications:
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Responsible Party: Adaliene Versiani M. Ferreira, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03103984    
Other Study ID Numbers: 30409114.8.0000.5149
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adaliene Versiani M. Ferreira, Federal University of Minas Gerais:
Obesity
Liver transplantation
weight loss diet
immunosuppression
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes