Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition

Last updated: February 26, 2025
Sponsor: Abbott Nutrition
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Vitreous Hemorrhage

Diabetic Foot Ulcers

Diabetic Retinopathy

Treatment

Oral Nutritional Supplement (ONS)

Clinical Study ID

NCT05913193
DA31
  • Ages > 30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Type 2 diabetes on treatment with one or more oral antidiabetics/insulin andconstant dose for at least 2 months

  • Has HbA1c < 9.0% based on recent (30 days prior to Baseline visit) laboratory valueor 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 anIndependent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to anyparticipation in the study to allow their data to be collected

  • Subject is under the care of a health care professional for malnutrition, or is atrisk for malnutrition (MUST≥1), and has recently (within the last 7 days prior toparticipating in this study) been prescribed study oral nutritional supplement (2servings/day) by their health care professional

Exclusion

Exclusion Criteria:

  • 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 constantdosage for at least 2 months prior to Baseline Visit

  • History of metabolic/endocrine (other than diabetes), hepatic (AST/ALT 3 times theupper 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., nomeat, dairy, eggs).

  • Is pregnant as confirmed via urine pregnancy test, attempting to conceive or notwilling and able to practice birth control during the study duration

  • Has current infection (requiring medication or which might be expected to requirehospitalization); has had inpatient surgery, or corticosteroid treatment (excludingtopical creams) in the last 3 months or antibiotics in the last 3 weeks prior toBaseline 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 allowedmedications, during the past 4 weeks that could profoundly affect (in the opinion ofthe PI or study physician) blood glucose or appetite modifying medications (examplesinclude orlistat, contrive, incretins, cannabis).

  • Has known dementia, eating disorders, history of significant neurological orpsychiatric disorder, or any other psychological condition that may interfere withstudy product consumption AND does not have a caregiver who can assist them withadherence to the study protocol

  • Participant in a concomitant AN trial or trial of a nonregistered drug (or is withinthe 30 days follow-up period for such a trial) or that otherwise conflicts with thisstudy unless otherwise approved by Abbott Nutrition.

  • Patient is receiving any other oral supplement with HMB for nutritional managementin the last 7 days

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: Oral Nutritional Supplement (ONS)
Phase:
Study Start date:
December 15, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Hospital Reina Sophia

    Córdoba, Cordoba 14004
    Spain

    Active - Recruiting

  • Hospital Especialidades Virgen De La Victoria

    Málaga, Malaga 29010
    Spain

    Active - Recruiting

  • Hospital Regional Malaga

    Málaga, Malaga 29010
    Spain

    Active - Recruiting

  • Hospital Albacete

    Albacete, 02008
    Spain

    Site Not Available

  • Hospital Vall D'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario Basurto

    Bilbao, 48013
    Spain

    Active - Recruiting

  • Hospital Uni. Puerta Del Mar

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Hospital Virgen De Las Nieves

    Granda, 18014
    Spain

    Active - Recruiting

  • Hospital Juhn Romon Jimenez

    Huelva, 21005
    Spain

    Active - Recruiting

  • Hospital Universitario Jaen

    Jaen, 23007
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario Insular-Materno infantil

    Las Palmas De Gran Canaria, 35016
    Spain

    Active - Recruiting

  • Hospital Clinico San Carlos

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Ramon y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Clinico Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Miguel Servet

    Zaragoza, 50009
    Spain

    Active - Recruiting

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