Association Between Dietary Factors and Chronic Subdural Hematoma (DISH) (DISH)

Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Other: Dietary and nutritional questionnaire; Other: Neurological function, cognitive function, and life quality assessment; Other: Peripheral blood test; Other: Metabonomic test; Other: Hematoma test

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 Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

• Study Contact: Name: Liang Wu, M.D.; Phone Number: +86 15001333582; Email: jasewl@sina.com
• Study Contact Backup: Name: Zhaofeng Zhang, Ph.D.

Study Locations

• China
  • Beijing, China, 100070
    • Recruiting
    • Beijing Tiantan Hospital, Capital Medical University
    • Sub-Investigator: Yunfei Li, M.D.
    • Contact: Liang Wu, M.D.; Phone Number: +8615001333582; Email: jasewl@sina.com
    • Principal Investigator: Weiming Liu, M.D.
    • Sub-Investigator: Liang Wu, M.D.
    • Sub-Investigator: Bingcheng Zhu, M.D.
  • Anhui
    • Huangshan, Anhui, China
      • Recruiting
      • Huangshan City People's Hospital
      • Contact: Jianbo Fang, M.D.; Phone Number: +86 15105590826; Email: drfantasy@139.com
      • Principal Investigator: Xianqing Fang, M.D.
      • Sub-Investigator: Jianbo Fang, M.D.
  • Jiangsu
    • Lianyungang, Jiangsu, China
      • Recruiting
      • First People's Hospital of Lianyungang
      • Contact: Hui Zhou, M.D.; Phone Number: +86 18961326536; Email: lygzhouhui@163.com
      • Principal Investigator: Hui Zhou, M.D.
  • Ningxia
    • Yinchuan, Ningxia, China
      • Recruiting
      • People's Hospital of Ningxia Hui Autonomous Region
      • Sub-Investigator: Min Li, M.D.
      • Principal Investigator: Dongming Ma, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

CSDH patients and non-CSDH, age- and gender-matched patients recruited from 4 medical centres in China.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group (CSDH group); CSDH patients recruited from neurosurgical department at 4 medical centres in China, which have apparent clinical symptoms and are confirmed by computed tomography or magnetic resonance imaging.	Other: Dietary and nutritional questionnaire; Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.; Other: Neurological function, cognitive function, and life quality assessment; 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.; Other: Peripheral blood test; Collect peripheral blood samples from patients.; Other: Metabonomic test; Collect urine and stool samples from patients.; Other: Hematoma test; Collect hematoma fluid, dura mater, and hematoma outer membrane samples from patients.
Control group (Healthy group); non-CSDH, age- and gender-matched patients recruited from ophthalmology, otolaryngology, and physical examination department at 4 medical centres in China.	Other: Dietary and nutritional questionnaire; Nutrition assessment, nutrient intake, dietary inflammatory index, and frailty status will be examined using questionnaires.; Other: Peripheral blood test; Collect peripheral blood samples from patients.; Other: Metabonomic test; Collect urine and stool samples from patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in dietary intakes	Difference in dietary intakes assessed by Food Frequency Questionnaire, a common method for measuring dietary intake in large epidemiological studies.	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.	When subjects are enrolled
Difference in nutritional status	Difference in nutritional status measured by Mini-Nutritional Assessment.	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.	When subjects are enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	When subjects are enrolled
Difference in metabolomics of gut, urine, and serum between case group and control group	Changes of metabolites in gut, urine, and serum will be measured by metabolomic mass spectrometry.	When subjects are enrolled

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Weiming Liu, M.D., Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Food frequency questionnaire; Chronic subdural hematoma; Dietary inflammatory index; Modified frailty index
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: HX-B-2022062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No