NCT05913193已完成不适用
High Calorie and High Protein Diabetes-specific Oral Nutritional Supplement in Type 2 Diabetes Subjects With or at Risk of Malnutrition in Real-life Setting: A Post-marketing Observational Study (PMO)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 17
- 主要终点
- Nutritional status risk by MUST
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Nutritional status risk by MUST
时间窗: Baseline to Day 90
Change in status as assessed by the Malnutrition Universal Screening Tool (MUST); Higher score indicates greater risk of malnutrition
次要结局
- Blood Glycemic Measurement(Baseline to Day 90)
- Handgrip Strength(Baseline to Day 90)
- EQ-5D Quality of Life(Baseline to Day 90)
- Subjective Global Assessment(Baseline to Day 90)
- Global Leadership Initiative on Malnutrition (GLIM) Diagnosis of Malnutrition(Baseline to Day 90)
- Chair Stand Test(Baseline to Day 90)
- Body Composition(Baseline to Day 90)
- Diabetes Distress Scale(Baseline to Day 90)
研究者
研究点 (17)
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