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临床试验/NCT01761851
NCT01761851已完成不适用

Metabolic and Nutritional Assessment in Patients on the Waiting List for Liver Transplantation

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Resting energy expenditure

研究概览

简要总结

Metabolic disorders and malnutrition are well known and have been reported in patients with chronic liver disease, but the relationship of energy metabolism and changes in nutritional status in patients on the waiting list for liver transplantation are unexplored. The aim of this study was to assess the resting energy expenditure (REE) of these patients, identifying the prevalence of hyper and hypometabolism. In addition, to assess if, malnutrition and clinical variables were associated with REE and metabolic disorders.

详细描述

This cross-sectional and descriptive study was carried out at the Alfa Institute of Gastroenterology, Hospital of Clinics, Universidade Federal of Minas Gerais (UFMG). The research protocol was approved by the UFMG Ethics Committee. Patients with indication for liver transplantation, aged over 20 years who regularly attended the Liver Outpatient Transplant Clinic were included after having agreed and signed the informed consent form. The presence of endocrine abnormalities (hyper/hypothyroidism) and patients on the waiting list for a double or re-transplant were excluding conditions. The REE and nutritional status assessment were performed by the same trained investigator (LGF) in order to reduce errors.

Resting Energy Expenditure - REE was measured by indirect calorimetry using a gas analyzer K4b2 (Cosmed, Rome, Italy). The test was performed in a silent, temperature-controlled room (22-24oC) in the morning, between 08:00am and 09:30am. The patients fasted for 12 hours, and remained on the lying position for about 20 minutes before the beginning of the test. The device was calibrated before each exam. The volume of inspired oxygen (VO2) and exhaled carbon dioxide (VCO2) was collected through a turbine and a sample line, adapted to the face mask, applied to the patient and, connected to the unit. The collection of gases occurred for 25 minutes, and the first 5 minutes were discarded. The mean VO2 and VCO2 per minute were used to calculate the REE according to the Weir formula. The obtained data were multiplied by 1,440 to obtain the 24-hour REE. Therefore, the REE was divided by kilograms of fat free mass - FFM (REE/FFM). Predicted REE was calculated from the Harris and Benedict formula (REEHB). In patients with fluid retention (clinical evidence of ascites and/or limb edema) dry weight was calculated by deducting an estimated weight for ascites and/or limb edema. Hypermetabolic patients were identified if the ratio REE:REEHB was > 120% and hypometabolic patients were classified according to the ratio REE:REEHB < 80%. The non-protein respiratory quotient (RQ) was calculated by the formula VCO2/VO2. Oxidation rates of carbohydrate and fat were expressed as percentages of total generated energy.

Nutritional Assessment - Nutritional status was provided by the Subjective Global Assessment (SGA), anthropometric measurements, handgrip strength, bioimpedance and energy balance (EB) analyses. The SGA adapted for patients on the waiting list for liver transplantation is based on clinical history and physical examination, as well as the presence of existing conditions such as encephalopathy, chronic or recurrent infection, varicose veins and renal function. Patients were classified as nourished and those classified as suspected or moderately malnourished and severely malnourished were grouped together to form the malnourished group.

Anthropometric evaluation was comprised of weight, height, body mass index (BMI), triceps and subscapular skinfold thickness (TSF and SSF respectively, measured with the Lange Skinfold Caliper - Cambridge Scientific Industries Inc., Cambridge, MD, USA), midarm circumference (MAC, measured with inextensible tape), arm muscle area (AMA) and arm fat area (AFA). To minimize practical variability, the average of three consecutive measurements was recorded. Values of TSF, SSF, MAC, AMA and AFA below the 5th percentile and BMI below 18.5kg/m2 (or 22.0kg/m2 for elderly) were considered as malnutrition.

Handgrip strength (HS) was assessed with the Jamar Handgrip Dynamometer (Preston, Jackson, MI, USA) using the non-dominant arm, and the mean of three measurements was determined. Malnutrition was defined as values of HS below the 5th percentile.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients who agreed to participate and signed the informed consent

排除标准

  • those who refused to participate

结局指标

主要结局

Resting energy expenditure

时间窗: 12 months

Assess resting energy expenditure

次要结局

  • Metabolic alterations - hyper or hypo metabolism(12 months)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Isabel Toulson Davisson Correia

Principal investigator

Federal University of Minas Gerais

研究点 (1)

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