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Completed

NCT Number: NCT03766620

A Tube Feeding Study in Malnourished Population With Diabetes

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital San Pedro, Logroño, La Rioja, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Body Weight Change

    Time frame: Baseline to Study Exit Week 12

    Measured in Kg

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 6, 2018
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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