NCT05913193Completed
Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition
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)
Source: ClinicalTrials.gov · Last updated 28 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 231 (actual)
- First submitted
- 30 May 2023
- Start date
- 15 Dec 2023
- Primary completion date
- 17 Jun 2025
- Lead sponsor
- Abbott Nutrition
- Diseases
- Type 2 diabetes
- NCT number
- NCT05913193
What you commit to
- Study type: Observational
- Participants enrolled: 231
- From 15 Dec 2023 to the primary completion date, 17 Jun 2025
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- If on thyroid medication or hormone replacement therapy, has not been on a constant dosage for at least 2 months prior to Baseline Visit
- 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.
- 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
Other illness
- History of T2D longer than 30 years
- History of diabetic ketoacidosis and or hyperosmolar hyperglycemic state (HHS)
- History of heart failure (\> class II)
- Has an active malignancy
- Known to be allergic or intolerant to any ingredient found in the study products
- 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
Lab values
- 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)
- 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).
Other
- 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).
- Is pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration
Who the study is looking for
- 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
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Hospital Uni. Puerta Del Mar Coordinator of this site? Confirm its status | Cadiz | Spain | Unknown status |
| Hospital Reina Sophia Coordinator of this site? Confirm its status | Córdoba | Spain | Unknown status |
| Hospital Virgen de las Nieves Coordinator of this site? Confirm its status | Granda | Spain | Unknown status |
| Hospital Juhn Romon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Unknown status |
| Hospital Universitario Jaen Coordinator of this site? Confirm its status | Jaén | Spain | Unknown status |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Unknown status |
| Hospital La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Regional Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Especialidades Virgen De La Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Virgen Del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital Clínico Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.