Appetite and Related Factors in Patients With ALS

July 7, 2021 updated by: Peking University Third Hospital

Detection of Appetite and Analysis of Related Factors in Patients With Amyotrophic Lateral Sclerosis (ALS)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100098
        • Recruiting
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ALS patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CNAQ≤28
ALS patients with CNAQ ≤ 28
Diagnostic test: Appetite rating scale CNAQ
Chinese version of Appetite rating scale CNAQ
CNAQ>28
ALS patients with CNAQ > 28
Diagnostic test: Appetite rating scale CNAQ
Chinese version of Appetite rating scale CNAQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ALSFRS-R score
Time Frame: 3 months
3 months
ALSFRS-R score
Time Frame: 6 months
6 months
ALSFRS-R score
Time Frame: 12 months
12 months
Food intake
Time Frame: 3 months
Inability to eat
3 months
Food intake
Time Frame: 6 months
Inability to eat
6 months
Food intake
Time Frame: 12 months
Inability to eat
12 months
invasive ventilator or death
Time Frame: 3 months
end point events
3 months
invasive ventilator or death
Time Frame: 6 months
end point events
6 months
invasive ventilator or death
Time Frame: 12 months
end point events
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

June 27, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M2020399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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