Trials / Completed
CompletedNCT03487536
Nutritional Prognostic Factors in ALS
Nutritional Prognostic Factors in Patients With Amyotrophic Lateral Sclerosis and Percutaneous Endoscopic Gastrostomy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 47 (actual)
- Sponsor
- University of Bari · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Nutritional assessment | BMI and cholesterol levels evaluation |
Timeline
- Start date
- 2006-01-02
- Primary completion
- 2015-06-30
- Completion
- 2016-07-31
- First posted
- 2018-04-04
- Last updated
- 2018-04-05
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03487536. Inclusion in this directory is not an endorsement.