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

Launched by ABBOTT NUTRITION · Jun 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how an oral nutritional supplement, specifically designed for people with diabetes, can help improve the nutritional health of adults with Type 2 diabetes (T2D) who are at risk of malnutrition. Participants will take this supplement twice a day as part of a nutritional support program. The main goal is to see if this supplement can make a positive difference in their overall nutrition.

To be eligible for the trial, participants should be at least 30 years old, have T2D that is being treated with medications, and have a recent blood test showing good control of their diabetes. They also need to have been prescribed the nutritional supplement by their healthcare provider. During the trial, participants can expect to follow the study guidelines and provide feedback on their experience. It's important to know that certain health conditions and medications may exclude someone from participating, so potential participants should discuss their individual situation with their healthcare provider.

Gender

ALL

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
• • 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