Nutritional Prognostic Factors in ALS

Completed

• Conditions: Neuro-Degenerative Disease; Gastrostomy; Nutritional Deficiency

• Registration Number: NCT03487536
• Lead Sponsor: University of Bari

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.

Study Timeline

• Study Start: 2006-01-02
• Primary Completion: 2015-06-30
• Study Completion: 2016-07-31
• Study First Submitted: 2018-03-19
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-03
• Last Update Submitted: 2018-04-03
• Study First Posted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinic Hospital; 🇮🇹 Bari, Italy