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OpenTrials
Completed

NCT Number: NCT03487536

Nutritional Prognostic Factors in ALS

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.

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Key information

Conditions

Nutritional Deficiency Gastrostomy Malnutrition Neuro-Degenerative Disease Nutrition Disorders Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinic Hospital

Bari, 70124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional Assessment

Other

BMI and cholesterol levels evaluation

Primary outcomes

  1. nutritional assessment

    Time frame: at the time of PEG placement (one day)

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

  2. biochemical nutritional assessment

    Time frame: only at the time of PEG placement (one day)

    cholesterol levels

Secondary outcomes

  1. body composition assessment

    Time frame: within 2 months from the PEG implantation (one day)

    Evaluation of fat mass and fat free mass

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Acronym: PEG-ALS

Important dates

Study start
2006
Primary completion
2015
Study completion
2016
First posted
Apr 4, 2018
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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