Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

Beijing Tiantan Hospital420 enrolled

Overview

A prospective, multicenter, case control trial is designed to compare difference in dietary and nutritional factors in patients with and without chronic subdural hematoma.

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.

Study Type

OBSERVATIONAL

Enrollment

420

Conditions

Chronic Subdural Hematoma

Interventions

Dietary and nutritional questionnaireOTHER

Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.

Neurological function, cognitive function, and life quality assessmentOTHER

Neurological function, cognitive function, and life quality will be examined using Glasgow Coma Scale, Modified Rankin Scale, Markwalder Grade Scale, Mini-mental state examination, and EuroQol five dimensions questionnaire.

Peripheral blood testOTHER

Collect peripheral blood samples from patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

Case group (CSDH group) Inclusion Criteria: * 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.

Locations (4)

Huangshan City People's Hospital

Huangshan City, Anhui, China

RECRUITING

First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

RECRUITING

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

RECRUITING

Outcomes

Primary Outcomes

Difference in dietary intakes

Difference in dietary intakes assessed by Food Frequency Questionnaire, a common method for measuring dietary intake in large epidemiological studies.

Time frame: When subjects are enrolled

Difference in Dietary Inflammatory Index score

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.

Time frame: When subjects are enrolled

Difference in nutritional status

Difference in nutritional status measured by Mini-Nutritional Assessment.

Time frame: When subjects are enrolled

Difference in frailty status

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.

Time frame: When subjects are enrolled

Secondary Outcomes

Difference in gut microbiota measured by 16S rRNA between case group and control group

Fecal sample will be measured by 16S rRNA sequencing. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample. The PCA, PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.

Central Contacts

Liang Wu, M.D.

CONTACT

15001333582 jasewl@sina.com

Zhaofeng Zhang, Ph.D.

CONTACT

Data from ClinicalTrials.gov

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