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ObesityNCT03103984

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

A study testing Weight loss diet in people with Obesity and Liver Transplantation, run by Federal University of Minas Gerais at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Liver Transplantation
What is being tested?
Weight loss diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
Jul 2014to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital da Clínicas da UFMG

    Belo Horizonte, Minas Gerais

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Weight loss diet
Keywords
Obesity, Liver transplantation, weight loss diet, immunosuppression
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight loss dietOther

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

Study groups in NCT03103984
Study groupRoleWhat they receive
ControlExperimentalThe volunteers (overweight and obese) will receive nutritional counseling and a weight loss diet.
Receives: Other: Weight loss diet
Immunosuppressed patientsExperimentalThe volunteers (liver transplantation) will receive nutritional counseling and a weight loss diet.
Receives: Other: Weight loss diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight measurement from baseline until 6 months follow up.

    The weight loss will be measured by weighing volunteers

    Measured: Baseline and 30, 60, 90 and 180 days

Secondary outcomes (13)

  1. 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.

    Measured: Baseline and 30, 60, 90 and 180 days

  2. Change in basal metabolic rate from baseline until 6 months follow up.

    Basal metabolic rate will be measured by calorimetry.

    Measured: Baseline and 30, 60, 90 and 180 days

  3. 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.

    Measured: Baseline and 30, 60, 90 and 180 days

  4. Change in depressive symptoms from baseline until 6 months follow up.

    Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory.

    Measured: Baseline and 30, 60, 90 and 180 days

  5. Change in anxiety symptoms from baseline until 6 months follow up.

    Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory.

    Measured: Baseline and 30, 60, 90 and 180 days

  6. 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.

    Measured: Baseline and 30, 60, 90 and 180 days

  7. Change in perceived stress from baseline until 6 months follow up.

    Nutritional effect in perceived stress will be measured by the Perceived Stress Scale.

    Measured: Baseline and 30, 60, 90 and 180 days

  8. 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.

    Measured: Baseline and 30, 60, 90 and 180 days

  9. 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.

    Measured: Baseline and 30, 60, 90 and 180 days

  10. Change in metabolic markers serum levels from baseline until 6 months follow up.

    Nutritional effect in the levels of triglycerides, cholesterol and glucose

    Measured: Baseline and 30, 60, 90 and 180 days

  11. 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.

    Measured: Baseline and 30, 60, 90 and 180 days

  12. 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.

    Measured: Baseline and 30, 60, 90 and 180 days

  13. 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.

    Measured: Baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2017
  2. Study startJul 2014
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03103984
Sponsor's protocol ID
30409114.8.0000.5149
Status last verified
Jun 2018
First submitted
27 Mar 2017
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 11448577

  • 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.

    PubMed 26717257

  • 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.

    PubMed 25142246

  • 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.

    PubMed 24517561

  • Rodrigues DF, Fagundes GBP, Monteiro BL, Monteze NM, Rodrigues AMDS, Vieira ELM, Teixeira AL, Teixeira MM, Oliveira MC, Correia MITD, Generoso SV, Ferreira AVM. Blunted inflammatory response is associated with a lower response to a weight loss dietary intervention in liver recipients. Clin Nutr. 2024 Oct;43(10):2438-2447. doi: 10.1016/j.clnu.2024.09.029. Epub 2024 Sep 17.

    PubMed 39305754

Questions about this trial

What is this clinical trial studying?

A study testing Weight loss diet in people with Obesity and Liver Transplantation, run by Federal University of Minas Gerais at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight measurement from baseline until 6 months follow up. (time frame: Baseline and 30, 60, 90 and 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03103984, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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