NCT04476056Unknown不适用
Analysis of Trans-sectoral Nutritional Care of Malnourished Patients With Chronic Pancreatitis Over 6 Months
University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria
研究概览
简要总结
Malnutrition and loss of muscle mass are common in patients with chronic pancreatitis. However, there is only limited data on nutritional treatment. In this study, malnourished patients with chronic pancreatitis will receive an intensified nutritional therapy to improve nutritional status. The aim of the study is that malnutrition in patients with chronic pancreatitis can be successfully treated.
详细描述
Malnutrition and sarcopenia are common complications in chronic pancreatitis leading to increased morbidity and mortality. Therefore nutritional therapy can be considered imperative. However, there is limited evidence on the treatment of malnutrition in patients with chronic pancreatitis. This study aims to investigate the effect of an intensified nutritional therapy on nutritional status in malnourished patients with chronic pancreatitis. By testing feasibility of this intensified therapy valuable recommendations for future treatment of malnutrition in patients with chronic pancreatitis can be derived.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pancreatitis verified by histology or imaging modality (endoscopic ultrasound, computed tomography, magnetic resonance imaging, magnetic resonance cholangiopancreatography)
- •Diagnosis of malnutrition
排除标准
- •Pregnant or breast feeding
- •Implanted defibrillator or pacemaker
- •History of pancreatic Cancer
- •Any other malignant tumor disease within the last 3 years
- •Concomitant liver cirrhosis
结局指标
主要结局
Changes in Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) Criteria
时间窗: 6 months
Changes from baseline prevalence of malnutrition according to the European Society for Clinical Nutrition and Metabolism criteria after 6 months
次要结局
- Gait Speed(28 days, 3 months, 6 months)
- Plasma Metabolome(28 days, 3 months, 6 months)
- Plasma Transcriptome(28 days, 3 months, 6 months)
- Interleukin-1 Beta(28 days, 3 months, 6 months)
- Sarcopenia according to EWGSOP 2 (European Working Group on Sarcopenia in Older People 2) criteria(28 days, 3 months, 6 months)
- Extracellular Water(28 days, 3 months, 6 months)
- Tumor Necrosis Factor Alpha(28 days, 3 months, 6 months)
- Malnutrition Status according to ESPEN (European Society for Clinical Nutrition and Metabolism) criteria(28 days, 3 months, 6 months)
- Malnutrition according to GLIM (Global Leadership Initiative on Malnutrition) criteria(28 days, 3 months, 6 months)
- Reduced Body Mass Index(28 days, 3 months, 6 months)
- Reduced Skeletal Muscle Mass Index(28 days, 3 months, 6 months)
- Reduced Gait Speed(28 days, 3 months, 6 months)
- Reduced Muscle Strength(28 days, 3 months, 6 months)
- Phase Angle(28 days, 3 months, 6 months)
- Compliance to Dietary Counselling(28 days, 3 months, 6 months)
- Waist Circumference(28 days, 3 months, 6 months)
- Waist-to-Hip Ratio(28 days, 3 months, 6 months)
- Skeletal Muscle Mass(28 days, 3 months, 6 months)
- Total Body Water(28 days, 3 months, 6 months)
- Hematocrit(28 days, 3 months, 6 months)
- Magnesium(28 days, 3 months, 6 months)
- Alanine Aminotransferase(28 days, 3 months, 6 months)
- Compliance to Oral Nutritional Supplements(28 days, 3 months, 6 months)
- Triceps Skinfold Thickness(28 days, 3 months, 6 months)
- Upper Arm Circumference(28 days, 3 months, 6 months)
- Dietary Fiber Intake(28 days, 3 months, 6 months)
- Mean Corpuscular Hemoglobin Concentration(28 days, 3 months, 6 months)
- Potassium(28 days, 3 months, 6 months)
- Phosphate(28 days, 3 months, 6 months)
- Aspartate Transaminase(28 days, 3 months, 6 months)
- C-reactive Protein(28 days, 3 months, 6 months)
- Albumin(28 days, 3 months, 6 months)
- Creatinine(28 days, 3 months, 6 months)
- High-density Lipoprotein Cholesterol(28 days, 3 months, 6 months)
- Zinc(28 days, 3 months, 6 months)
- Anxiety and Depression(28 days, 3 months, 6 months)
- Body Weight(28 days, 3 months, 6 months)
- Hip Circumference(28 days, 3 months, 6 months)
- Dropout Rate(28 days, 3 months, 6 months)
- Reduced Fat Free Mass Index(28 days, 3 months, 6 months)
- Height(28 days, 3 months, 6 months)
- Body Mass Index(28 days, 3 months, 6 months)
- Fat Free Mass(28 days, 3 months, 6 months)
- Energy Intake(28 days, 3 months, 6 months)
- Fat Intake(28 days, 3 months, 6 months)
- Calcium(28 days, 3 months, 6 months)
- Gamma-glutamyl Transferase(28 days, 3 months, 6 months)
- Urea(28 days, 3 months, 6 months)
- Glucose(28 days, 3 months, 6 months)
- Intestinal Microbiome(28 days, 3 months, 6 months)
- Fat Mass(28 days, 3 months, 6 months)
- Low-density Lipoprotein Cholesterol(28 days, 3 months, 6 months)
- Fatigue(28 days, 3 months, 6 months)
- Protein Intake(28 days, 3 months, 6 months)
- Hemoglobin(28 days, 3 months, 6 months)
- Bilirubin(28 days, 3 months, 6 months)
- Interleukin-6(28 days, 3 months, 6 months)
- Glycated hemoglobin(28 days, 3 months, 6 months)
- Hand Grip Strength(28 days, 3 months, 6 months)
- Carbohydrate Intake(28 days, 3 months, 6 months)
- Physical Activity(28 days, 3 months, 6 months)
- Mean Corpuscular Volume(28 days, 3 months, 6 months)
- Reticulocyte Count(28 days, 3 months, 6 months)
- Sodium(28 days, 3 months, 6 months)
- Alkaline Phosphatase(28 days, 3 months, 6 months)
- Uric Acid(28 days, 3 months, 6 months)
- Insulin(28 days, 3 months, 6 months)
- Total Cholesterol(28 days, 3 months, 6 months)
- Non-essential Fatty Acids(28 days, 3 months, 6 months)
- Triglycerides(28 days, 3 months, 6 months)
- Iron(28 days, 3 months, 6 months)
- Loneliness(28 days, 3 months, 6 months)
研究者
研究点 (2)
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