Nutritional Prognostic Factors in ALS

Nutritional Deficiency Clinical Trial

— PEG-ALS  

Official title:

Nutritional Prognostic Factors in Patients With Amyotrophic Lateral Sclerosis and Percutaneous Endoscopic Gastrostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487536
• Other study ID #: Policlinic Hospital 2, Bari
• Status: Completed
• First received: March 19, 2018
• Last updated: April 3, 2018
• Start date: January 2, 2006
• Est. completion date: July 31, 2016

Study information

• Verified date: April 2018
• Source: University of Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background. Several nutritional factors have been evaluated as prognostic factors for survival in ALS patients at earlier stages of the disease [body mass index (BMI), body composition expressed as fat free mass (FFM), fat mass (FM), phase angle (PhA), low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratio, cholesterol levels], while only two studies have evaluated some of these parameters after PEG placement.

Aim. BMI and cholesterol levels were evaluated as prognostic factors for survival after percutaneous endoscopic gastrostomy (PEG) placement Moreover, the relationship between body composition and BMI in a subgroup of ALS patients was evaluated.

Description:

Methods. Nutritional and neurological parameters were assessed at the time of PEG placement (T0) in 47 consecutive patients. Body composition and PhA were measured in only 22 patients within 2 months from T0. Survival was calculated as the time from the PEG placement to tracheostomy or death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 31, 2016
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit

Exclusion Criteria:

• ALS patients without PEG

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Gastrostomy
• Malnutrition
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Nutritional Deficiency

Intervention

Other:
• Nutritional assessment
BMI and cholesterol levels evaluation

Locations

Country	Name	City	State
Italy	Policlinic Hospital	Bari

Sponsors (1)

Lead Sponsor	Collaborator
University of Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nutritional assessment	Weight and height (combined to report BMI in kg/m^2)	at the time of PEG placement (one day)
Primary	biochemical nutritional assessment	cholesterol levels	only at the time of PEG placement (one day)
Secondary	body composition assessment	Evaluation of fat mass and fat free mass	within 2 months from the PEG implantation (one day)