Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 4
- 主要终点
- Difference in dietary intakes
研究概览
简要总结
A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.
详细描述
Chronic subdural hematoma (CSDH) is one of the most common neurosurgical conditions, which is considered to be an inflammatory disease. Dietary factors can have an impact on the inflammatory mechanism in human body, which can increase a variety of inflammatory biomarkers in the blood. The risk of malnutrition in the elderly is generally high, and nutritional status can affect the risk of CSDH in the elderly. Little is known about the association of dietary factors with CSDH. The investigators speculate that dietary factors participate in and promote the occurrence and development of CSDH. This study will clarify whether there is a correlation between dietary factors and CSDH, which will reveal the pathogenesis and prevention of CSDH.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
- •CSDH verified on cranial computed tomography or magnetic resonance imaging.
- •Written informed consent from patients or their next of kin according to the patient's cognitive status.
- •Control group (Healthy group)
- •Inclusion Criteria:
- •non-CSDH patients (18 years to 90 years) with matched age and gender.
- •Written informed consent from patients or their next of kin according to the patient's cognitive status.
- •Exclusion Criteria for both case and control group:
- •Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before.
- •CSDH turned from acute subdural hematoma.
- •Existing malignant tumors, poor medication condition or severe comorbidity.
- •Difficulty in feeding requiring long-term enteral or parenteral nutrition support.
- •Dietary and nutritional survey is estimated to be completed difficultly.
- •Reproductive-age women without verified negative pregnancy testing.
- •Participating in other research.
排除标准
- 未提供
结局指标
主要结局
Difference in dietary intakes
时间窗: When subjects are enrolled
Difference in dietary intakes assessed by Food Frequency Questionnaire, a common method for measuring dietary intake in large epidemiological studies.
Difference in Dietary Inflammatory Index score
时间窗: When subjects are enrolled
The Dietary Inflammatory Index (DII) score of the current nutritional status of patients with and without CSDH will be evaluated. The amounts of nutrients will be calculated using last 3-month nutrient analysis program. DII score will calculate from these foods. The z-score must first be calculated. To calculate the z-score, the standard global consumption amount is subtracted from the average consumption amount of the individual. The result obtained is divided by the standard deviation value. The z score found with this result is converted to the percentile score. The percentile value is multiplied by the full inflammatory effect score. DII is obtained as a result of summing the scores calculated for all nutrients. Found DII is an indicator of the inflammatory load of the individual's daily diet.
Difference in nutritional status
时间窗: When subjects are enrolled
Difference in nutritional status measured by Mini-Nutritional Assessment.
Difference in frailty status
时间窗: When subjects are enrolled
Difference in frailty status measured by Modified Frailty Index. Modified Frailty Index ranges from score 0 to 1, and frail status is defined as a score of ≥0.27.
次要结局
- Difference in gut microbiota measured by 16S rRNA between case group and control group(When subjects are enrolled)
- Difference in metabolomics of gut, urine, and serum between case group and control group(When subjects are enrolled)
研究者
Weiming Liu
Professor
Beijing Tiantan Hospital