Immunosuppression and Diet: the Role of Inflammation in the Adipose Tissue Remodeling After Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in weight measurement from baseline until 6 months follow up.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CONTROL GROUP: Women/men aged 18-60 years old; Body mass index 25-40 kg/m
- •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.
排除标准
- •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.
研究组 & 干预措施
Control
The volunteers (overweight and obese) will receive nutritional counseling and a weight loss diet.
干预措施: Weight loss diet (Other)
Immunosuppressed patients
The volunteers (liver transplantation) will receive nutritional counseling and a weight loss diet.
干预措施: Weight loss diet (Other)
结局指标
主要结局
Change in weight measurement from baseline until 6 months follow up.
时间窗: Baseline and 30, 60, 90 and 180 days
The weight loss will be measured by weighing volunteers
次要结局
- Change in inflammatory mediators serum levels from baseline until 6 months follow up.(Baseline and 30, 60, 90 and 180 days)
- Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up.(Baseline and 30, 60, 90 and 180 days)
- 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 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)
- Characterization of the immunological response of liver transplanted patients from baseline until 6 months follow up..(Baseline and 30, 60, 90 and 180 days)
- Change in quality of life from baseline until 6 months follow up.(Baseline and 30, 60, 90 and 180 days)
- Changes in serum levels of neurotrophic factors from baseline until 6 months follow up.(Baseline and 30, 60, 90 and 180 days)
- Change in perceived stress from baseline until 6 months follow up.(Baseline and 30, 60, 90 and 180 days)
- Change in quality of diet from baseline until 6 months follow up.(Baseline and 30, 60, 90 and 180 days)
- Characterization of the immunological profile of liver transplanted patients in the baseline.(Baseline.)
- Change in metabolic markers serum levels from baseline until 6 months follow up.(Baseline and 30, 60, 90 and 180 days)
研究者
Adaliene Versiani M. Ferreira
PhD
Federal University of Minas Gerais