NCT03766620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

December 5, 2018

Last Update Submit

July 23, 2020

Conditions

Malnutrition; Diabetes

Outcome Measures

Primary Outcomes (1)

  • Body Weight Change

    Measured in Kg

    Baseline to Study Exit Week 12

Secondary Outcomes (7)

  • Malnutrition Universal Screening Tool (MUST)

    Baseline to Study Exit Week 12

  • Subjective Global Assessment (SGA)

    Baseline to Study Exit Week 12

  • Quality of life (EuroQol EQ-5D-5L)

    Baseline to Study Exit Week 12

  • Glucose control

    Baseline to Study Exit Week 12

  • Body Mass Index

    Baseline to Study Exit Week 12

  • +2 more secondary outcomes

Other Outcomes (2)

  • Functionality

    Baseline to Study Exit Week 12

  • Physician Product Satisfaction

    Baseline to Study Exit Week 12

Study Arms (1)

Tube Fed Participants

Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

Hospital Costa del Sol 3095

Marbella, Málaga, 29603, Spain

Location

Hospital Costa del Sol 3178

Marbella, Málaga, 29603, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Gomez-Ulla

Madrid, 28047, Spain

Location

Centro Médico San juan de la Cruz

Málaga, 29007, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

MalnutritionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Maria Camprubi Robles, PhD

    Abbott

    STUDY CHAIR

  • Angela M Palmero, MD

    Hospital San Pedro de La Rioja

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 6, 2018

Study Start

November 29, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

July 24, 2020

Record last verified: 2020-07

Locations

ES(8)