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Completed

NCT Number: NCT03103984

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

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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Key information

Conditions

Obesity Body Weight Liver Transplantation Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital da Clínicas da UFMG

Belo Horizonte, Minas Gerais, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight loss diet

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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