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

NCT ID: NCT05913193

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 231 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-15
• Study Completion Date: 2025-06-17

Brief 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.

Conditions

Malnutrition; Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Oral Nutritional Supplement (ONS) Group

2 servings per day as per standard of care during the study period

Oral Nutritional Supplement (ONS)

Intervention Type: OTHER

Diabetes specific oral nutritional supplement

Interventions

Oral Nutritional Supplement (ONS)

Diabetes specific oral nutritional supplement

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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 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).
• 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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

German Guzman, MD

Role: STUDY_CHAIR

Abbott

Locations

Hospital Reina Sophia

Córdoba, Cordoba, Spain

Hospital Especialidades Virgen De La Victoria

Málaga, Malaga, Spain

Hospital Regional Malaga

Málaga, Malaga, Spain

Hospital Universitario Basurto

Bilbao, , Spain

Hospital Uni. Puerta Del Mar

Cadiz, , Spain

Hospital Virgen De Las Nieves

Granda, , Spain

Hospital Juhn Romon Jimenez

Huelva, , Spain

Hospital Universitario Jaen

Jaén, , Spain

Complejo Hospitalario Universitario Insular-Materno infantil

Las Palmas de Gran Canaria, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital La Paz

Madrid, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Hospital Virgen Del Rocio

Seville, , Spain

Hospital Clinico Valencia

Valencia, , Spain

Hospital La Fe

Valencia, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Countries

Spain

Other Identifiers

DA31

Identifier Type: -

Identifier Source: org_study_id