Clinical Trials Directory

Trials / Completed

CompletedNCT03487536

Nutritional Prognostic Factors in ALS

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

Status
Completed
Phase
Study type
Observational
Enrollment
47 (actual)
Sponsor
University of Bari · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNutritional assessmentBMI and cholesterol levels evaluation

Timeline

Start date
2006-01-02
Primary completion
2015-06-30
Completion
2016-07-31
First posted
2018-04-04
Last updated
2018-04-05

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03487536. Inclusion in this directory is not an endorsement.