Diabetes, Malnutrition
Conditions
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.
Interventions
Diabetes specific oral nutritional supplement
Sponsors
Abbott Nutrition
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Blood Glycemic Measurement | Baseline to Day 90 | Change in glycemic control markers where lower levels are associated with improved control |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Study Product Compliance | Baseline to Day 90 | Participant completed daily record of nutritional support program |
Countries
Spain
Outcome results
None listed