Nutritional Prognostic Factors in ALS

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03487536

Acronym

PEG-ALS

Enrollment

Registered

2018-04-04

Start date

2006-01-02

Completion date

2016-07-31

Last updated

2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrostomy, Neuro-Degenerative Disease, Nutritional Deficiency

Brief 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.

Detailed 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.

Interventions

OTHERNutritional assessment

BMI and cholesterol levels evaluation

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
nutritional assessment	at the time of PEG placement (one day)	Weight and height (combined to report BMI in kg/m\^2)
biochemical nutritional assessment	only at the time of PEG placement (one day)	cholesterol levels

Secondary

Measure	Time frame	Description
body composition assessment	within 2 months from the PEG implantation (one day)	Evaluation of fat mass and fat free mass

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026