Appetite and Related Factors in Patients With ALS

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Diagnostic Test: Appetite rating scale CNAQ

• Registration Number: NCT04953624
• Lead Sponsor: Peking University Third Hospital

Brief Summary

Chinese cnaq scale was used to evaluate the appetite changes of Chinese ALS patients; Objective to investigate the related factors of appetite changes in ALS patients; Objective to investigate the effect of anorexia on the progression and survival of ALS patients.

Detailed Description

1. With the consent of the original author, the scale was translated and back translated, and the Chinese version of the scale was determined after communication and confirmation with the original author.

2. Cnaq was used to measure the appetite of the patients, and hads was used to measure the anxiety and depression of the patients;

3. Analyze the proportion of loss of appetite in ALS group, compare the differences of clinical characteristics such as ALSFRS-R score, weight, BMI value, cognitive status such as ECAs score between patients with loss of appetite and patients without loss of appetite in ALS group, and conduct correlation analysis.

4. The patients were followed up every three months until they were unable to eat or end-point events (invasive ventilator or death), and the correlation between cnaq and disease progression and survival was analyzed.

Study Timeline

• Study Start: 2020-08-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-08
• Last Update Posted: 2021-07-08
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• ALS patients diagnosed as probable, or definite according to the revised El Escorial criteria

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Exclusion Criteria

• there are other chronic consumption diseases such as severe digestive system diseases, thyroid diseases, diabetes and so on.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CNAQ>28	Appetite rating scale CNAQ	ALS patients with CNAQ \> 28
CNAQ≤28	Appetite rating scale CNAQ	ALS patients with CNAQ ≤ 28

Primary Outcome Measures

Name	Time	Method
invasive ventilator or death	12 months	end point events
ALSFRS-R score	12 months
Food intake	12 months	Inability to eat

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China