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)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Malnutrition
• Intervention / Treatment: Other: Oral Nutritional Supplement (ONS)

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: Kristen S DeLuca, MS, RDN, LDN; Phone Number: 6145653522; Email: kristen.deluca@abbott.com

Study Locations

• Spain
  • Albacete, Spain, 02008
    • Recruiting
    • Hospital Albacete
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Vall d'Hebron
  • Cadiz, Spain, 11009
    • Recruiting
    • Hospital Uni. Puerta Del Mar
  • Jaen, Spain, 23007
    • Recruiting
    • Hospital Universitario Jaen
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de octubre
  • Madrid, Spain
    • Recruiting
    • Hospital Ramon y Cajal
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital La Paz
  • Madrid, Spain, 28050
    • Recruiting
    • Hospital Clinico San Carlos
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Virgen del Rocío
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital La Fe
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Valencia
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Miguel Servet
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Recruiting
      • Hospital Reina Sophia
  • Malaga
    • Málaga, Malaga, Spain, 29010
      • Recruiting
      • Hospital Especialidades Virgen De La Victoria
    • Málaga, Malaga, Spain, 29010
      • Recruiting
      • Hospital Regional Malaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oral Nutritional Supplement (ONS) Group; 2 servings per day as per standard of care during the study period	Other: Oral Nutritional Supplement (ONS); Diabetes specific oral nutritional supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glycemic Measurement	Change in glycemic control markers where lower levels are associated with improved control	Baseline to Day 90
Handgrip Strength	Change in handgrip as measured in kg	Baseline to Day 90
Chair Stand Test	Change in test score where higher number of times completed is more favorable	Baseline to Day 90
Body Composition	Change in body composition where increased fat free mass is more favorable	Baseline to Day 90
EQ-5D Quality of Life	Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.	Baseline to Day 90
Diabetes Distress Scale	Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable	Baseline to Day 90
Subjective Global Assessment	Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished	Baseline to Day 90
Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition	Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria	Baseline to Day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Product Compliance	Participant completed daily record of nutritional support program	Baseline to Day 90
Participant Satisfaction Survey	Participant assessed 4 questions related to the nutritional support program scored from 1 to 10 where higher number is more favorable	Day 90 or Early Exit
Health Care Professional Satisfaction Survey	Health Care Professional assessed 8 questions related to each Participant's study experience	Day 90 or Early Exit
Medication Usage	Medications prescribed for glucose or appetite control	Baseline to Day 60 to Day 90
Body Mass Index	As calculated from Height and Weight	Baseline to Day 90
Calf Circumference	Measured in cm	Baseline to Day 90

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: German Guzman, MD, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Nutrition Disorders; Diabetes Mellitus; Malnutrition
• Other Study ID Numbers: DA31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No