We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Appetite and Related Factors in Patients With ALS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04953624
Recruitment Status : Recruiting
First Posted : July 8, 2021
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Diagnostic Test: Appetite rating scale CNAQ

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Detection of Appetite and Analysis of Related Factors in Patients With Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022


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




Primary Outcome Measures :
  1. ALSFRS-R score [ Time Frame: 3 months ]
  2. ALSFRS-R score [ Time Frame: 6 months ]
  3. ALSFRS-R score [ Time Frame: 12 months ]
  4. Food intake [ Time Frame: 3 months ]
    Inability to eat

  5. Food intake [ Time Frame: 6 months ]
    Inability to eat

  6. Food intake [ Time Frame: 12 months ]
    Inability to eat

  7. invasive ventilator or death [ Time Frame: 3 months ]
    end point events

  8. invasive ventilator or death [ Time Frame: 6 months ]
    end point events

  9. invasive ventilator or death [ Time Frame: 12 months ]
    end point events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ALS patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04953624


Contacts
Layout table for location contacts
Contact: Dongsheng Fan +86 13701023871 dsfan@sina.com

Locations
Layout table for location information
China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100098
Contact: Dongsheng Fan         
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dongsheng Fan Peking University Third Hospital
Layout table for additonal information
Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04953624    
Other Study ID Numbers: M2020399
First Posted: July 8, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases