Association Between Dietary Factors and Chronic Subdural Hematoma (DISH)

Recruiting

• Conditions: Chronic Subdural Hematoma

• Registration Number: NCT05599217
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-31
• Study Start: 2023-03-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 420

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in dietary intakes	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	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	When subjects are enrolled	Difference in nutritional status measured by Mini-Nutritional Assessment.
Difference in frailty status	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.

Secondary Outcome Measures

Name	Time	Method
Difference in gut microbiota measured by 16S rRNA between case group and control group	When subjects are enrolled	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.
Difference in metabolomics of gut, urine, and serum between case group and control group	When subjects are enrolled	Changes of metabolites in gut, urine, and serum will be measured by metabolomic mass spectrometry.

Trial Locations

Locations (4)

Huangshan City People's Hospital; 🇨🇳 Huangshan, Anhui, China

First People's Hospital of Lianyungang; 🇨🇳 Lianyungang, Jiangsu, China

People's Hospital of Ningxia Hui Autonomous Region; 🇨🇳 Yinchuan, Ningxia, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China