A Tube Feeding Study in Malnourished Population With Diabetes

Completed

• Conditions: Malnutrition; Diabetes

• Registration Number: NCT03766620
• Lead Sponsor: Abbott Nutrition

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-29
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Weight Change	Baseline to Study Exit Week 12	Measured in Kg

Secondary Outcome Measures

Name	Time	Method
Subjective Global Assessment (SGA)	Baseline to Study Exit Week 12	HCP completed nutrition assessment
Malnutrition Universal Screening Tool (MUST)	Baseline to Study Exit Week 12	HCP completed screening tool
Body Mass Index	Baseline to Study Exit Week 12	BMI calculated Weight (kg)/Height (m)2
Glucose control	Baseline to Study Exit Week 12	HbA1c levels
Product Compliance	Baseline to Study Exit Week 12	Product consumption diary
Quality of life (EuroQol EQ-5D-5L)	Baseline to Study Exit Week 12	Subject rated health state of 5 dimensions. Each dimension has 5-levels scaled in negative direction resulting in an overall 5-digit number describing the health state; EQ VAS Score 0-100 points scaled in positive direction
Albumin Levels	Baseline to Study Exit Week 12	Nutrition status parameter collected per standard of care

Trial Locations

Locations (8)

Hospital Gomez-Ulla; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Centro Médico San juan de la Cruz; 🇪🇸 Málaga, Spain

Hospital General Universitario de Valencia; 🇪🇸 València, Spain

Hospital San Pedro; 🇪🇸 Logroño, La Rioja, Spain

Hospital Costa del Sol 3178; 🇪🇸 Marbella, Málaga, Spain

Hospital Costa del Sol 3095; 🇪🇸 Marbella, Málaga, Spain