Clinical trial NCT03766620: A Tube Feeding Study in Malnourished Population With Diabetes
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition; Diabetes
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2018-12-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects, men and women who meet all enrollment criteria, will be enrolled from study centers in Spain.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study
* Considered malnourished, or at risk for malnutrition
* Diagnosed with diabetes mellitus type 1 or 2 and treated with oral hypoglycemic medications and/or exogenous insulin
* Conforms to the requirements set forth on the study product label
* Under the care of a health care professional for malnutrition and has recently been prescribed tube feeding as a sole-source of nutrition by their health care professional
* Free living, residing in a nursing home or admitted to the hospital and has anticipated length of hospital stay \> 3 days and \< 12 days

Exclusion Criteria:

* Severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Cannot safely consume the study product, or known to be allergic or intolerant to any ingredient found in the study product
* Renal or liver failure
* Participates in another study that has not been approved as a concomitant study by AN

Primary outcomes:
measure: Body Weight Change
timeFrame: Baseline to Study Exit Week 12
Secondary outcomes:
measure: Malnutrition Universal Screening Tool (MUST)
timeFrame: Baseline to Study Exit Week 12
measure: Subjective Global Assessment (SGA)
timeFrame: Baseline to Study Exit Week 12
measure: Quality of life (EuroQol EQ-5D-5L)
timeFrame: Baseline to Study Exit Week 12
measure: Glucose control
timeFrame: Baseline to Study Exit Week 12
measure: Body Mass Index
timeFrame: Baseline to Study Exit Week 12
measure: Product Compliance
timeFrame: Baseline to Study Exit Week 12
measure: Albumin Levels
timeFrame: Baseline to Study Exit Week 12
Other outcomes:
measure: Functionality
timeFrame: Baseline to Study Exit Week 12
measure: Physician Product Satisfaction
timeFrame: Baseline to Study Exit Week 12
Locations:
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
city: Marbella
country: Spain
facility: Hospital Costa del Sol 3095
state: Málaga
city: Marbella
country: Spain
facility: Hospital Costa del Sol 3178
state: Málaga
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Gomez-Ulla
city: Málaga
country: Spain
facility: Centro Médico San juan de la Cruz
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: València
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
affiliation: Abbott
name: Maria Camprubi Robles, PhD
role: STUDY_CHAIR
affiliation: Hospital San Pedro de La Rioja
name: Angela M Palmero, MD
role: STUDY_CHAIR
References: