This multicenter, prospective study will evaluate the use of a nutritional support program including an oral diabetes-specific nutritional supplement consumed twice a day on the nutritional status of patients with T2D with or at risk of malnutrition.
Study Type
OBSERVATIONAL
Enrollment
231
Diabetes specific oral nutritional supplement
Hospital Reina Sophia
Córdoba, Cordoba, Spain
Hospital Especialidades Virgen De La Victoria
Málaga, Malaga, Spain
Hospital Regional Malaga
Nutritional status risk by MUST
Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition
Time frame: Baseline to Day 90
Blood Glycemic Measurement
Change in glycemic control markers where lower levels are associated with improved control
Time frame: Baseline to Day 90
Handgrip Strength
Change in handgrip as measured in kg
Time frame: Baseline to Day 90
Chair Stand Test
Change in test score where higher number of times completed is more favorable
Time frame: Baseline to Day 90
Body Composition
Change in body composition where increased fat free mass is more favorable
Time frame: Baseline to Day 90
EQ-5D Quality of Life
Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time frame: Baseline to Day 90
Diabetes Distress Scale
Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable
Time frame: Baseline to Day 90
Subjective Global Assessment
Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished
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Málaga, Malaga, Spain
Hospital Universitario Basurto
Bilbao, Spain
Hospital Uni. Puerta Del Mar
Cadiz, Spain
Hospital Virgen De Las Nieves
Granda, Spain
Hospital Juhn Romon Jimenez
Huelva, Spain
Hospital Universitario Jaen
Jaén, Spain
Complejo Hospitalario Universitario Insular-Materno infantil
Las Palmas de Gran Canaria, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
...and 7 more locations
Time frame: Baseline to Day 90
Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition
Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria
Time frame: Baseline to Day 90