Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Nutritional status risk by MUST [Baseline to Day 90]
Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition
Secondary Outcome Measures
- Blood Glycemic Measurement [Baseline to Day 90]
Change in glycemic control markers where lower levels are associated with improved control
- Handgrip Strength [Baseline to Day 90]
Change in handgrip as measured in kg
- Chair Stand Test [Baseline to Day 90]
Change in test score where higher number of times completed is more favorable
- Body Composition [Baseline to Day 90]
Change in body composition where increased fat free mass is more favorable
- EQ-5D Quality of Life [Baseline to Day 90]
Participant assessed 5 Domains; Each Domain scored from 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
- Diabetes Distress Scale [Baseline to Day 90]
Participant assessed 29 questions rated from 1 to 5 where higher number if less favorable
- Subjective Global Assessment [Baseline to Day 90]
Healthcare Professional completed assessment of 4 components resulting in score where A = Well Nourished, B = Moderately Malnourished, and C = Severely Malnourished
- Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition [Baseline to Day 90]
Change in GLIM as calculated from MUST malnutrition risk and Phenotypic and Etiological Criteria
Other Outcome Measures
- Study Product Compliance [Baseline to Day 90]
Participant completed daily record of nutritional support program
- Participant Satisfaction Survey [Day 90 or Early Exit]
Participant assessed 4 questions related to the nutritional support program scored from 1 to 10 where higher number is more favorable
- Health Care Professional Satisfaction Survey [Day 90 or Early Exit]
Health Care Professional assessed 8 questions related to each Participant's study experience
- Medication Usage [Baseline to Day 60 to Day 90]
Medications prescribed for glucose or appetite control
- Body Mass Index [Baseline to Day 90]
As calculated from Height and Weight
- Calf Circumference [Baseline to Day 90]
Measured in cm
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Type 2 diabetes on treatment with one or more oral antidiabetics/insulin and constant dose for at least 2 months
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Has HbA1c < 9.0% based on recent (30 days prior to Baseline visit) laboratory value or analysis of blood sample obtained at Baseline Visit
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Adult population with age ≥30 years
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Willing to follow the protocol as described
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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
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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:
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History of T2D longer than 30 years
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History of diabetic ketoacidosis and or hyperosmolar hyperglycemic state (HHS)
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If on thyroid medication or hormone replacement therapy, has not been on a constant dosage for at least 2 months prior to Baseline Visit
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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)
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History of heart failure (> class II)
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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).
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Is pregnant as confirmed via urine pregnancy test, attempting to conceive or not willing and able to practice birth control during the study duration
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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.
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Has an active malignancy
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Known to be allergic or intolerant to any ingredient found in the study products
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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).
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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
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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.
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Patient is receiving any other oral supplement with HMB for nutritional management in the last 7 days
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Abbott Nutrition
Investigators
- Study Chair: German Guzman, MD, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DA31