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)

Abbott Nutrition17 sites in 1 country231 target enrollmentDecember 15, 2023

ConditionsMalnutrition Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Malnutrition
Sponsor: Abbott Nutrition
Enrollment: 231
Locations: 17
Primary Endpoint: Nutritional status risk by MUST
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2023

End Date

June 17, 2025

Last Updated

8 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Nutritional status risk by MUST

Time Frame: Baseline to Day 90

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

Secondary Outcomes

Blood Glycemic Measurement(Baseline to Day 90)
Handgrip Strength(Baseline to Day 90)
EQ-5D Quality of Life(Baseline to Day 90)
Subjective Global Assessment(Baseline to Day 90)
Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition(Baseline to Day 90)
Chair Stand Test(Baseline to Day 90)
Body Composition(Baseline to Day 90)
Diabetes Distress Scale(Baseline to Day 90)