Association Between Dietary Factors and Chronic Subdural Hematoma: a Multicenter Case-control Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Subdural Hematoma
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 420
- Locations
- 4
- Primary Endpoint
- Difference in dietary intakes
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Weiming Liu
Professor
Beijing Tiantan Hospital
Eligibility Criteria
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Difference in dietary intakes
Time Frame: 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
Time Frame: 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
Time Frame: When subjects are enrolled
Difference in nutritional status measured by Mini-Nutritional Assessment.
Difference in frailty status
Time Frame: 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 Outcomes
- 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)