A Prospective, Observational Study, of a High Calorie, High Protein Tube Feeding With Slow Release Carbohydrates and Monounsaturated Fatty Acids (MUFA), in a Malnourished Population With Diabetes
Sponsor study identifier
observational
49
1 country
8
Study Start
November 29, 2018
Actual (reported)Primary Completion
July 1, 2020
Actual (reported)Study Completion
July 1, 2020
Actual (reported)This is a prospective, non-interventional, observational study. Malnourished subjects with diabetes, who are receiving a high calorie, high protein tube feeding with slow release carbohydrates and MUFA by their health care professional (HCP) per standard of care will be enrolled into the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 29, 2018
Actual (reported)December 5, 2018
Actual (reported)December 6, 2018
Actual (reported)July 1, 2020
Actual (reported)July 1, 2020
Actual (reported)Body Weight Change
Measured in Kg
Baseline to Study Exit Week 12
Malnutrition Universal Screening Tool (MUST)
Baseline to Study Exit Week 12
Subjective Global Assessment (SGA)
Baseline to Study Exit Week 12
Quality of life (EuroQol EQ-5D-5L)
Baseline to Study Exit Week 12
Glucose control
Baseline to Study Exit Week 12
Body Mass Index
Baseline to Study Exit Week 12
Functionality
Baseline to Study Exit Week 12
Physician Product Satisfaction
Baseline to Study Exit Week 12
Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition.
Subjects, men and women who meet all enrollment criteria, will be enrolled from study centers in Spain.
Hospital San Pedro
Logroño, La Rioja, 26006, Spain
Hospital Costa del Sol 3095
Marbella, Málaga, 29603, Spain
Hospital Costa del Sol 3178
Marbella, Málaga, 29603, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Gomez-Ulla
Madrid, 28047, Spain
Centro Médico San juan de la Cruz
Málaga, 29007, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Maria Camprubi Robles, PhD
Abbott
Angela M Palmero, MD
Hospital San Pedro de La Rioja
49 participants (actual enrollment reported by the registry).
First Submitted
December 5, 2018
First Posted
December 6, 2018
Study Start
November 29, 2018
Actual (reported)Contact the study team to confirm eligibility.
Hospital Clínico Universitario de Valladolid
Valladolid, 47003, Spain
Primary Completion
July 1, 2020
Actual (reported)Study Completion
July 1, 2020
Actual (reported)Last Updated
July 24, 2020
Record last verified: 2020-07
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Source: ClinicalTrials.gov.
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