oral nutritional supplement in type 2 diabetes subjects with or at risk of malnutrition

Conditions: Malnutrition; Diabetes

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.


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