Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition (NCT05913193) | Clinical Trial Compass
CompletedNot Applicable
Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition
Spain231 participantsStarted 2023-12-15
Plain-language 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.
Who can participate
Age range30 Years
SexALL
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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), stric…