MalnutritionNCT05913193
Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition
An observational study of Malnutrition and Diabetes, run by Abbott Nutrition at 17 sites in Spain.
Trial summary
This multicenter, prospective study will evaluate the use of a nutritional support program including an oral diabetes-specific nutritional supplement consumed twice a day on the nutritional status of patients with T2D with or at risk of malnutrition. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Malnutrition, Diabetes
- What is being tested?
- Oral Nutritional Supplement (ONS)
- Type of treatment
- Pill or oral medicine
- How many people
- 231 participants
- Where
- 17 sitesSpain
- Study dates
- 15 Dec 2023to 17 Jun 2025
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with type 2 diabetes receiving an oral nutritional supplement as standard of care will be recruited from the investigator's community population.
Who may be able to join
- Type 2 diabetes on treatment with one or more oral antidiabetics/insulin and constant dose for at least 2 months
- Has HbA1c < 9.0% based on recent (30 days prior to Baseline visit) laboratory value or analysis of blood sample obtained at Baseline Visit
- Adult population with age ≥30 years
- Willing to follow the protocol as described
- Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study to allow their data to be collected
- Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition (MUST≥1), and has recently (within the last 7 days prior to participating in this study) been prescribed study oral nutritional supplement (2 servings/day) by their health care professional
Who cannot join
- History of T2D longer than 30 years
- History of diabetic ketoacidosis and or hyperosmolar hyperglycemic state (HHS)
- If on thyroid medication or hormone replacement therapy, has not been on a constant dosage for at least 2 months prior to Baseline Visit
- History of metabolic/endocrine (other than diabetes), hepatic (AST/ALT 3 times the upper normal limit), or significant renal disease (GFR < 60 ml/min/1.73m2)
- History of heart failure (> class II)
- Follows a non-typical eating pattern, such as very low carbohydrate diet (e.g., Atkins diet, ketogenic diet, high protein diet), strict vegetarianism (e.g., no meat, dairy, eggs).
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- Is pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration
- Has current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks prior to Baseline Visit.
- Has an active malignancy
- Known to be allergic or intolerant to any ingredient found in the study products
- Taking any medications, herbals, or dietary supplements, other than allowed medications, during the past 4 weeks that could profoundly affect (in the opinion of the PI or study physician) blood glucose or appetite modifying medications (examples include orlistat, contrive, incretins, cannabis).
- Has known dementia, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol
- Participant in a concomitant AN trial or trial of a nonregistered drug (or is within the 30 days follow-up period for such a trial) or that otherwise conflicts with this study unless otherwise approved by Abbott Nutrition.
- Patient is receiving any other oral supplement with HMB for nutritional management in the last 7 days
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Spain17 sites
Hospital Universitario Basurto
Bilbao, 48013
Hospital Uni. Puerta Del Mar
Cadiz, 11009
Hospital Reina Sophia
Córdoba, Cordoba, 14004
Hospital Virgen De Las Nieves
Granda, 18014
Hospital Juhn Romon Jimenez
Huelva, 21005
Hospital Universitario Jaen
Jaén, 23007
Complejo Hospitalario Universitario Insular-Materno infantil
Las Palmas de Gran Canaria, 35016
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital La Paz
Madrid, 28046
Hospital Clinico San Carlos
Madrid, 28050
Hospital Ramon y Cajal
Madrid
Hospital Especialidades Virgen De La Victoria
Málaga, Malaga, 29010
Hospital Regional Malaga
Málaga, Malaga, 29010
Hospital Virgen Del Rocio
Seville, 41013
Hospital Clinico Valencia
Valencia, 46010
Hospital La Fe
Valencia, 46026
Hospital Miguel Servet
Zaragoza, 50009
About this study
Official title: High Calorie and High Protein Diabetes-specific Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition in Real-life Setting: A Post-marketing Observational Study (PMO)
This multicenter, prospective study will evaluate the use of a nutritional support program including an oral diabetes-specific nutritional supplement consumed twice a day on the nutritional status of patients with T2D with or at risk of malnutrition.
- Conditions
- Malnutrition, Diabetes
- Being tested
- Oral Nutritional Supplement (ONS)
- 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.
Oral Nutritional Supplement (ONS)Other
Diabetes specific oral nutritional supplement
| Study group | Role | What they receive |
|---|---|---|
| Oral Nutritional Supplement (ONS) Group | 2 servings per day as per standard of care during the study period Receives: Other: Oral Nutritional Supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status risk by MUST
Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition
Measured: Baseline to Day 90
Secondary outcomes (8)
Blood Glycemic Measurement
Change in glycemic control markers where lower levels are associated with improved control
Measured: Baseline to Day 90
Handgrip Strength
Change in handgrip as measured in kg
Measured: Baseline to Day 90
Chair Stand Test
Change in test score where higher number of times completed is more favorable
Measured: Baseline to Day 90
Body Composition
Change in body composition where increased fat free mass is more favorable
Measured: Baseline to Day 90
EQ-5D Quality of Life
Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Baseline to Day 90
Diabetes Distress Scale
Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable
Measured: Baseline to Day 90
Subjective Global Assessment
Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished
Measured: Baseline to Day 90
Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition
Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria
Measured: Baseline to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Dec 2023
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies 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
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- German Guzman, MD, Study chair, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913193
- Sponsor's protocol ID
- DA31
- Status last verified
- Aug 2025
- First submitted
- 30 May 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Calorie and High Protein Diabetes-specific Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition in Real-life Setting: A Post-marketing Observational Study (PMO)
- ClinicalTrials.gov ID
- NCT05913193
- Acronym / sponsor ID
- DA31
- Conditions
- Malnutrition, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 22 Jun 2023 (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 multicenter, prospective study will evaluate the use of a nutritional support program including an oral diabetes-specific nutritional supplement consumed twice a day on the nutritional status of patients with T2D with or at risk of malnutrition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Nutritional Supplement (ONS) Group | – | Other: Oral Nutritional Supplement (ONS)2 servings per day as per standard of care during the study period |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with type 2 diabetes receiving an oral nutritional supplement as standard of care will be recruited from the investigator's community population.
Key inclusion criteria (6 listed)
- Type 2 diabetes on treatment with one or more oral antidiabetics/insulin and constant dose for at least 2 months
- Has HbA1c < 9.0% based on recent (30 days prior to Baseline visit) laboratory value or analysis of blood sample obtained at Baseline Visit
- Adult population with age ≥30 years
- Willing to follow the protocol as described
- Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any participation in the study to allow their data to be collected
Key exclusion criteria (14 listed)
- History of T2D longer than 30 years
- History of diabetic ketoacidosis and or hyperosmolar hyperglycemic state (HHS)
- If on thyroid medication or hormone replacement therapy, has not been on a constant dosage for at least 2 months prior to Baseline Visit
- History of metabolic/endocrine (other than diabetes), hepatic (AST/ALT 3 times the upper normal limit), or significant renal disease (GFR < 60 ml/min/1.73m2)
- History of heart failure (> class II)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional Supplement (ONS)Diabetes specific oral nutritional supplement | Other | Oral Nutritional Supplement (ONS) Group |
Primary outcome
Nutritional status risk by MUST
Time frame: Baseline to Day 90
Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition
8 secondary outcomes
Blood Glycemic Measurement
Time frame: Baseline to Day 90
Handgrip Strength
Time frame: Baseline to Day 90
Chair Stand Test
Time frame: Baseline to Day 90
Body Composition
Time frame: Baseline to Day 90
EQ-5D Quality of Life
Time frame: Baseline to Day 90
Diabetes Distress Scale
Time frame: Baseline to Day 90
Subjective Global Assessment
Time frame: Baseline to Day 90
Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition
Time frame: Baseline to Day 90
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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
German Guzman, MD study chair
Abbott
17 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 and Diabetes, run by Abbott Nutrition at 17 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 14 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Nutritional status risk by MUST (time frame: Baseline to Day 90). 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 28 Aug 2025.