Immunosuppression and Diet: the Role of Inflammation in the Adipose Tissue Remodeling
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jul 2014
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 27, 2017
CompletedFirst Posted
Study publicly available on registry
April 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJune 26, 2018
June 1, 2018
3.3 years
March 27, 2017
June 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in weight measurement from baseline until 6 months follow up.
The weight loss will be measured by weighing volunteers
Baseline and 30, 60, 90 and 180 days
Secondary Outcomes (13)
Change in body composition from baseline until 6 months follow up.
Baseline and 30, 60, 90 and 180 days
Change in basal metabolic rate from baseline until 6 months follow up.
Baseline and 30, 60, 90 and 180 days
Change in inflammatory mediators serum levels from baseline until 6 months follow up.
Baseline and 30, 60, 90 and 180 days
Change in depressive symptoms from baseline until 6 months follow up.
Baseline and 30, 60, 90 and 180 days
Change in anxiety symptoms from baseline until 6 months follow up.
Baseline and 30, 60, 90 and 180 days
- +8 more secondary outcomes
Study Arms (2)
Control
EXPERIMENTALThe volunteers (overweight and obese) will receive nutritional counseling and a weight loss diet.
Immunosuppressed patients
EXPERIMENTALThe volunteers (liver transplantation) will receive nutritional counseling and a weight loss diet.
Interventions
Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital da Clínicas da UFMG
Belo Horizonte, Minas Gerais, Brazil
Related Publications (5)
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.
PMID: 11448577BACKGROUNDTerjimanian 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.
PMID: 26717257BACKGROUNDNoceti 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.
PMID: 25142246BACKGROUNDAnastacio 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.
PMID: 24517561BACKGROUNDRodrigues 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.
PMID: 39305754DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Débora Fernandes Rodrigues, Master
UFMG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 27, 2017
First Posted
April 7, 2017
Study Start
July 1, 2014
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
June 26, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share