Integration of Nutritional Metabolomics With Bioenergetics in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry
研究概览
简要总结
With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal health in cystic fibrosis (CF). This project is designed to investigate nutrition-related factors, such as diet and body composition, on outcomes in patients with CF. The data generated from this study will be used to inform future nutrition intervention studies in adults with CF and CFRD.
详细描述
Research methods include blood draws for plasma markers of oxidative stress and metabolomics (the measurement of thousands of small chemicals in the blood), magnetic resonance imaging (MRI, to assess energy capacity and thigh fat), dual energy X-ray absorptiometry (DEXA, to assess total and regional body fat and muscle), and indirect calorimetry (to assess resting energy expenditure and whole body fat oxidation). Clinically-relevant data, such as lung function, CF genotype, and diabetes status will be obtained from the electronic medical record and the CF Registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have confirmed CF diagnosis with at least one Class I to III CFTR mutations
- •age ≥ 18 yrs
- •on a clinically-stable medical regimen for 3 wks
- •no intravenous or oral antibiotics for at least 3 wks prior to study visit
排除标准
- •current pregnancy
- •unwilling or unable to discontinue enteral tube feeds for one night before the study visit, if applicable
- •most recent FEV1% <40%
- •drug (recreational or prescription) or alcohol abuse
- •pacemaker or any electronic implantable device
- •unable to give informed consent
- •Healthy volunteers
- •Inclusion criteria:
- •18-50 yrs of age
- •ambulatory status
- •absence of hospitalization in the previous year except for accidents
- •Exclusion criteria:
- •current pregnancy
- •current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years
- •current respiratory disease including asthma, chronic obstructive pulmonary disorder, or emphysema
- •current chronic autoimmune or pro-inflammatory disease
- •history of tuberculosis, HIV, or other chronic infection
- •previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or other glucose lowering medication
- •advanced (≥ stage 3) renal disease
- •body mass index (BMI) ≥ 30 kg/m2
- •acute illness (such as a viral infection) within the past 2 weeks
- •current use of any prescription medications that would indicate presence of an acute or chronic medical condition that may influence study results
- •drug (recreational or prescription) or alcohol abuse
- •weight instability (± 10% body weight within the last 6 months) or current participation in weight loss or weight gain program
- •inability to provide informed consent.
结局指标
主要结局
Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry
时间窗: Baseline for cross-sectional study and 1 year for longitudinal study
This will pe performed using targeted metabolomics methods
次要结局
- quantitative plasma levels of specific plasma acylcarnitines(Baseline for cross-sectional study and 1 year for longitudinal study)
研究者
Jessica Alvarez
Assistant Professor
Emory University