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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
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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario Basurto
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BilbaoSpainUnknown status
Hospital Uni. Puerta Del Mar
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CadizSpainUnknown status
Hospital Reina Sophia
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CórdobaSpainUnknown status
Hospital Virgen de las Nieves
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GrandaSpainUnknown status
Hospital Juhn Romon Jimenez
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HuelvaSpainUnknown status
Hospital Universitario Jaen
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JaénSpainUnknown status
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainUnknown status
Hospital La Paz
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MadridSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Ramón y Cajal
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MadridSpainUnknown status
Hospital Regional Malaga
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MálagaSpainUnknown status
Hospital Especialidades Virgen De La Victoria
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MálagaSpainUnknown status
Hospital Virgen Del Rocio
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SevilleSpainUnknown status
Hospital Clínico Valencia
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ValenciaSpainUnknown status
Hospital La Fe
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ValenciaSpainUnknown status
Hospital Miguel Servet
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ZaragozaSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.