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A Tube Feeding Study in Malnourished Population With Diabetes

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ClinicalTrials.gov Identifier: NCT03766620
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Malnutrition; Diabetes

Study Type : Observational
Estimated Enrollment : 100 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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766620


Contacts
Contact: Kristen DeLuca 614-624-5455 kristen.deluca@abbott.com

Locations
Spain
Hospital Universitario de Cabueñes Not yet recruiting
Gijón, Asturias, Spain, 33394
Hospital Universitario Germans Trias I Pujol Not yet recruiting
Badalona, Barcelona, Spain, 08916
Hospital Punta Europa 3094 Not yet recruiting
Algeciras, Cádiz, Spain, 11207
Hospital Punta Europa 3176 Not yet recruiting
Algeciras, Cádiz, Spain, 11207
Hospital San Pedro Not yet recruiting
Logroño, La Rioja, Spain, 26006
Hospital Costa del Sol 3095 Not yet recruiting
Marbella, Málaga, Spain, 29603
Hospital Costa del Sol 3177 Not yet recruiting
Marbella, Málaga, Spain, 29603
Hospital Costa del Sol 3178 Not yet recruiting
Marbella, Málaga, Spain, 29603
Hospital de Navarra Recruiting
Pamplona,, Navarra, Spain, 31008
Hospitalital de la Ribera Not yet recruiting
Alcira, Valencia, Spain, 46600
Hospital del Mar Not yet recruiting
Barcelona, Spain, 08003
Hospital Universitario Vall d´Hebrón Not yet recruiting
Barcelona, Spain, 08035
Hospital Clinico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Hospital Universitario Principe de Asturias 3092 Not yet recruiting
Madrid, Spain, 28805
Hospital Universitario Principe de Asturias 3175 Not yet recruiting
Madrid, Spain, 28805
Centro Médico San juan de la Cruz Recruiting
Málaga, Spain, 29007
Hospital Clínico Universitario de Valladolid Recruiting
Valladolid, Spain, 47003
Hospital General Universitario de Valencia Not yet recruiting
València, Spain, 46014
Hospital Universitario y Politécnico de La Fe 3065 Not yet recruiting
València, Spain, 46026
Hospital Universitario y Politécnico de La Fe 3096 Not yet recruiting
València, Spain, 46026
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Maria Camprubi Robles, PhD Abbott

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT03766620     History of Changes
Other Study ID Numbers: DA14
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
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