Malnutrition; DiabetesNCT03766620
A Tube Feeding Study in Malnourished Population With Diabetes
An observational study of Malnutrition; Diabetes, run by Abbott Nutrition at 8 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition; Diabetes
- How many people
- 49 participants
- Where
- 8 sitesSpain
- Study dates
- 29 Nov 2018to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects, men and women who meet all enrollment criteria, will be enrolled from study centers in Spain.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital San Pedro
Logroño, La Rioja, 26006
Hospital Universitario La Paz
Madrid, 28046
Hospital Gomez-Ulla
Madrid, 28047
Centro Médico San juan de la Cruz
Málaga, 29007
Hospital Costa del Sol 3095
Marbella, Málaga, 29603
Hospital Costa del Sol 3178
Marbella, Málaga, 29603
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
About this study
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
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.
- Conditions
- Malnutrition; Diabetes
- Medical subject headings
- Malnutrition, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tube Fed Participants | Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Change
Measured in Kg
Measured: Baseline to Study Exit Week 12
Secondary outcomes (7)
Malnutrition Universal Screening Tool (MUST)
HCP completed screening tool
Measured: Baseline to Study Exit Week 12
Subjective Global Assessment (SGA)
HCP completed nutrition assessment
Measured: Baseline to Study Exit Week 12
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
Measured: Baseline to Study Exit Week 12
Glucose control
HbA1c levels
Measured: Baseline to Study Exit Week 12
Body Mass Index
BMI calculated Weight (kg)/Height (m)2
Measured: Baseline to Study Exit Week 12
Product Compliance
Product consumption diary
Measured: Baseline to Study Exit Week 12
Albumin Levels
Nutrition status parameter collected per standard of care
Measured: Baseline to Study Exit Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start29 Nov 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition; DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Camprubi Robles, PhD, Study chair, AbbottAngela M Palmero, MD, Study chair, Hospital San Pedro de La Rioja
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766620
- Sponsor's protocol ID
- DA14
- Status last verified
- Jul 2020
- First submitted
- 5 Dec 2018
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03766620
- Acronym / sponsor ID
- DA14
- Conditions
- Malnutrition; Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tube Fed Participants | – | –Individuals with diabetes and malnutrition receiving tube feed as sole source nutrition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects, men and women who meet all enrollment criteria, will be enrolled from study centers in Spain.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body Weight Change
Time frame: Baseline to Study Exit Week 12
Measured in Kg
7 secondary outcomes
Malnutrition Universal Screening Tool (MUST)
Time frame: Baseline to Study Exit Week 12
Subjective Global Assessment (SGA)
Time frame: Baseline to Study Exit Week 12
Quality of life (EuroQol EQ-5D-5L)
Time frame: Baseline to Study Exit Week 12
Glucose control
Time frame: Baseline to Study Exit Week 12
Body Mass Index
Time frame: Baseline to Study Exit Week 12
Product Compliance
Time frame: Baseline to Study Exit Week 12
Albumin Levels
Time frame: Baseline to Study Exit Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Camprubi Robles, PhD study chair
Abbott
Angela M Palmero, MD study chair
Hospital San Pedro de La Rioja
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition; Diabetes, run by Abbott Nutrition at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight Change (time frame: Baseline to Study Exit Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.