- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07658612
Research on the Possible Relationship Between Sarcopenia and Oral Muscle Function (GSOM)
A Study on the Correlation Between the Genetic Polymorphisms of Elderly Individuals in the Community and Possible Sarcopenia and Oral Muscle Function
This study will focus on community-dwelling elderly individuals and will follow the community screening process recommended by AWGS.
It is expected to recruit 100 individuals who may have sarcopenia and 300 healthy or sub-healthy elderly individuals who are not likely to have sarcopenia, totaling 400 participants.Basic data such as age and body composition will be collected, as well as dietary records (three days), nutritional status assessments (Mini Nutritional Assessment, MNA), and oral health status records (including records of missing teeth, the number of opposing teeth, and whether participants wear fixed or removable dentures).
Chewing and swallowing abilities will be recorded using the Eating Assessment Tool (EAT-10). In a non-invasive manner, saliva samples will be collected for genomic DNA (gDNA) extraction, followed by quantitative gDNA typing analysis of seven gene loci (shown in Table 3).
Genotype data will be statistically analyzed along with participants' basic information, relevant sarcopenia screening data, and parameters related to oral health and swallowing function. This study adopts a case-control experimental design with the following objectives:
- to explore the incidence of possible sarcopenia in community-dwelling elderly.
- to investigate the relationship between oral function and possible sarcopenia in community-dwelling elderly using tongue pressure measurements.
- to understand the correlation between sarcopenia risk in community-dwelling elderly and seven specific genes.
- to examine the relationship between oral function and seven specific genes in community-dwelling elderly.
- to investigate the relationship between tongue pressure measurements and the values measured using edible chewing gum.
- to establish a standard test for evaluating oral chewing function using edible chewing gum.
By examining the possible mechanisms of the different genes involved in the causes of sarcopenia, we aim to find prevention strategies that are suitable for participants with different gene types.
연구 개요
상태
개입 / 치료
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
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Taoyuan, 대만
- Chang Gung University of Science and Technology
-
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Case group - Inclusion Criteria:
- aged 60 years (inclusive) or older
- general public or residing in an institution for 3 months (inclusive) or more
- willing to participate in the experimental design and sign the consent form
- able to eat independently by mouth
- identified by researchers as possibly having sarcopenia
Control group-Inclusion Criteria:
- aged 60 years (inclusive) or older
- general public or residing in an institution for 3 months (inclusive) or more ●willing to participate in the experimental design and sign the consent form
- able to eat independently by mouth
- identified by researchers as not possibly having sarcopenia
Case group 、Control group- Exclusion Criteria:
- having comorbidities, critical illnesses, undergoing major surgeries, cancer, renal failure, liver failure, kidney diseases, liver diseases, having malignant tumors in the past five years, inflammation symptoms (C-reactive protein >10mg/dl)
- severely malnourished individuals (GNRI < 82)
- long-term tube-fed individuals.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Case group
Possible sarcopenia
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NON
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|
Control group
Non-possible sarcopenia
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NON
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Based on the results of empirical research on sarcopenia in Asian countries, a diagnostic consensus was established.
기간: baseline
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baseline
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 202402045B0
- NMRPF3Q0291 (기타 식별자: Chang Gung University of Science and Technology)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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