Nutritional Prognostic Factors in ALS

NCT03487536 | Completed

• 1 other identifier: Policlinic Hospital 2, Bari
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Deficiency; Neuro-Degenerative Disease; Gastrostomy

Outcome Measures

Primary Outcomes (2)

• nutritional assessment

  Weight and height (combined to report BMI in kg/m\^2)

  at the time of PEG placement (one day)

• biochemical nutritional assessment

  cholesterol levels

  only at the time of PEG placement (one day)

Secondary Outcomes (1)

• body composition assessment

  within 2 months from the PEG implantation (one day)

Interventions

Nutritional assessment OTHER

BMI and cholesterol levels evaluation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study included 47 consecutive patients referring to the Neurological ALS Tertiary Centre, Department of Basic Medical Sciences, Neurosciences and Sense Organs, who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit, Department of Emergency and Organ Transplantation, of the same University Hospital. All patients fulfilled revised El Escorial criteria for probable or definite classical ALS.

You may qualify if:

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

You may not qualify if:

• ALS patients without PEG

Sponsors & Collaborators

• University of Bari: lead

Study Sites (1)

Policlinic Hospital

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Michele Barone

  University of Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 4, 2018
• Study Start: January 2, 2006
• Primary Completion: June 30, 2015
• Study Completion: July 31, 2016
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

IT (1)