A Tube Feeding Study in Malnourished Population With Diabetes

Malnutrition; Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766620
• Other study ID #: DA14
• Status: Completed
• Start date: November 29, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Malnutrition
• Malnutrition; Diabetes

Locations

Country	Name	City	State
Spain	Hospital San Pedro	Logroño	La Rioja
Spain	Hospital Gomez-Ulla	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Centro Médico San juan de la Cruz	Málaga
Spain	Hospital Costa del Sol 3095	Marbella	Málaga
Spain	Hospital Costa del Sol 3178	Marbella	Málaga
Spain	Hospital General Universitario de Valencia	València
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functionality	Barthel Index of Activities of Daily Living; Subject completed assessment of 10 functions; Sum of scores range from 0-20 scaled in positive direction	Baseline to Study Exit Week 12
Other	Physician Product Satisfaction	Physician Completed Questionnaire; 3 to 5 category responses scaled in negative direction	Baseline to Study Exit Week 12
Primary	Body Weight Change	Measured in Kg	Baseline to Study Exit Week 12
Secondary	Malnutrition Universal Screening Tool (MUST)	HCP completed screening tool	Baseline to Study Exit Week 12
Secondary	Subjective Global Assessment (SGA)	HCP completed nutrition assessment	Baseline to Study Exit Week 12
Secondary	Quality of life (EuroQol EQ-5D-5L)	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	Baseline to Study Exit Week 12
Secondary	Glucose control	HbA1c levels	Baseline to Study Exit Week 12
Secondary	Body Mass Index	BMI calculated Weight (kg)/Height (m)2	Baseline to Study Exit Week 12
Secondary	Product Compliance	Product consumption diary	Baseline to Study Exit Week 12
Secondary	Albumin Levels	Nutrition status parameter collected per standard of care	Baseline to Study Exit Week 12