Study Purpose:
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.
Study Status:
Not recruiting
Disease:
Nutritional Deficiency , Neuro-Degenerative Disease , Gastrostomy
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Michele Barone, University of Bari
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Full Study Summary:
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.
Study Sponsor:
University of Bari
Estimated Enrollment:
47
Estimated Study Start Date:
01 / 02 / 2006
Estimated Study Completion Date:
07 / 31 / 2016
Posting Last Modified Date:
04 / 05 / 2018
Date Study Added to neals.org:
04 / 04 / 2018
Minimum Age:
N/A
Maximum Age:
N/A
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
Policlinic Hospital
Bari 70124
Italy