Nutritional Prognostic Factors in ALS (PEG-ALS)

April 3, 2018 updated by: Michele Barone, University of Bari

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Policlinic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nutritional assessment
Time Frame: at the time of PEG placement (one day)
Weight and height (combined to report BMI in kg/m^2)
at the time of PEG placement (one day)
biochemical nutritional assessment
Time Frame: only at the time of PEG placement (one day)
cholesterol levels
only at the time of PEG placement (one day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body composition assessment
Time Frame: within 2 months from the PEG implantation (one day)
Evaluation of fat mass and fat free mass
within 2 months from the PEG implantation (one day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bari

Investigators

  • Principal Investigator: Michele Barone, University of Bari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2006

Primary Completion (ACTUAL)

June 30, 2015

Study Completion (ACTUAL)

July 31, 2016

Study Registration Dates

First Submitted

March 19, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (ACTUAL)

April 4, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Policlinic Hospital 2, Bari

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the results have not yet been shared with all the authors

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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