A Tube Feeding Study in Malnourished Population With Diabetes

• ClinicalTrials.gov Identifier: NCT03766620
• Recruitment Status: Completed
• First Posted: December 6, 2018
• Last Update Posted: July 24, 2020
• Sponsor: Abbott Nutrition
• Information provided by (Responsible Party): Abbott Nutrition

Study Description

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.

Condition or disease
Malnutrition; Diabetes

Study Design

• Study Type: Observational
• Actual Enrollment: 49 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: November 29, 2018
• Actual Primary Completion Date: July 1, 2020
• Actual Study Completion Date: July 1, 2020

Groups and Cohorts

Group/Cohort
Tube Fed Participants; Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition.

Outcome Measures

Primary Outcome Measures :

1. Body Weight Change [ Time Frame: Baseline to Study Exit Week 12 ]
   Measured in Kg

Secondary Outcome Measures :

1. Malnutrition Universal Screening Tool (MUST) [ Time Frame: Baseline to Study Exit Week 12 ]
   HCP completed screening tool
2. Subjective Global Assessment (SGA) [ Time Frame: Baseline to Study Exit Week 12 ]
   HCP completed nutrition assessment
3. Quality of life (EuroQol EQ-5D-5L) [ Time Frame: 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
4. Glucose control [ Time Frame: Baseline to Study Exit Week 12 ]
   HbA1c levels
5. Body Mass Index [ Time Frame: Baseline to Study Exit Week 12 ]
   BMI calculated Weight (kg)/Height (m)2
6. Product Compliance [ Time Frame: Baseline to Study Exit Week 12 ]
   Product consumption diary
7. Albumin Levels [ Time Frame: Baseline to Study Exit Week 12 ]
   Nutrition status parameter collected per standard of care

Other Outcome Measures:

1. Functionality [ Time Frame: Baseline to Study Exit Week 12 ]
   Barthel Index of Activities of Daily Living; Subject completed assessment of 10 functions; Sum of scores range from 0-20 scaled in positive direction
2. Physician Product Satisfaction [ Time Frame: Baseline to Study Exit Week 12 ]
   Physician Completed Questionnaire; 3 to 5 category responses scaled in negative direction

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Subjects, men and women who meet all enrollment criteria, will be enrolled from study centers in Spain.

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

Contacts and Locations

Locations

Spain

Hospital San Pedro

Logroño, La Rioja, Spain, 26006

Hospital Costa del Sol 3095

Marbella, Málaga, Spain, 29603

Hospital Costa del Sol 3178

Marbella, Málaga, Spain, 29603

Hospital Universitario La Paz

Madrid, Spain, 28046

Hospital Gomez-Ulla

Madrid, Spain, 28047

Centro Médico San juan de la Cruz

Málaga, Spain, 29007

Hospital Clínico Universitario de Valladolid

Valladolid, Spain, 47003

Hospital General Universitario de Valencia

València, Spain, 46014

Sponsors and Collaborators

Abbott Nutrition

Investigators

• Study Chair: Maria Camprubi Robles, PhD; Abbott
• Study Chair: Angela M Palmero, MD; Hospital San Pedro de La Rioja

More Information

• Responsible Party: Abbott Nutrition
• ClinicalTrials.gov Identifier: NCT03766620
• Other Study ID Numbers: DA14
• First Posted: December 6, 2018
• Last Update Posted: July 24, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Malnutrition; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders