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

NCT05913193 | Completed

• 1 other identifier: DA31
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 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

Outcome Measures

Primary Outcomes (1)

• Nutritional status risk by MUST

  Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition

  Baseline to Day 90

Secondary Outcomes (8)

• Blood Glycemic Measurement

  Baseline to Day 90

• Handgrip Strength

  Baseline to Day 90

• Chair Stand Test

  Baseline to Day 90

• Body Composition

  Baseline to Day 90

• EQ-5D Quality of Life

  Baseline to Day 90

Other Outcomes (6)

• Study Product Compliance

  Baseline to Day 90

• Participant Satisfaction Survey

  Day 90 or Early Exit

• Health Care Professional Satisfaction Survey

  Day 90 or Early Exit

Study Arms (1)

Oral Nutritional Supplement (ONS) Group

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

Other: Oral Nutritional Supplement (ONS)

Interventions

Oral Nutritional Supplement (ONS) OTHER

Diabetes specific oral nutritional supplement

Oral Nutritional Supplement (ONS) Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (17)

Hospital Reina Sophia

Córdoba, Cordoba, 14004, Spain

Location

Hospital Especialidades Virgen De La Victoria

Málaga, Malaga, 29010, Spain

Location

Hospital Regional Malaga

Málaga, Malaga, 29010, Spain

Location

Hospital Universitario Basurto

Bilbao, 48013, Spain

Location

Hospital Uni. Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital Virgen De Las Nieves

Granda, 18014, Spain

Location

Hospital Juhn Romon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitario Jaen

Jaén, 23007, Spain

Location

Complejo Hospitalario Universitario Insular-Materno infantil

Las Palmas de Gran Canaria, 35016, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Clinico San Carlos

Madrid, 28050, Spain

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

Hospital Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Clinico Valencia

Valencia, 46010, Spain

Location

Hospital La Fe

Valencia, 46026, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Malnutrition; Diabetes Mellitus

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• German Guzman, MD

  Abbott

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 22, 2023
• Study Start: December 15, 2023
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (17)