NCT07252765招募中不适用
Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice. STARLIGHT Study
Outcomes'1012 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2025年11月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 334
- 试验地点
- 12
- 主要终点
- Descriptive of study population
研究概览
简要总结
The objective of this observational study is to characterize the patient profile and nutritional treatment patterns of individuals with type 2 diabetes (T2D) or drug-induced diabetes who present with malnutrition, or are at risk of it, and who are prescribed a diabetes-specific oral nutritional supplement (ONS) that is high in calories and protein and contains soluble fiber.
Participants will complete a series of questionnaires during visits 1 and 3.
详细描述
- Background and Rationale This study focuses on patients with type 2 diabetes mellitus (T2D) who also present with malnutrition or are at risk of developing malnutrition. These conditions negatively affect clinical and functional outcomes, increasing the likelihood of complications and hospitalizations. The use of diabetes-specific oral nutritional supplements (ONS)-characterized by a high caloric and protein content and enriched with soluble fiber-may contribute to improving clinical status, nutritional parameters, and quality of life. Nevertheless, current evidence from real-world clinical practice remains limited and heterogeneous.
- Primary Objective To characterize the clinical and nutritional profile, as well as the nutritional treatment patterns, of patients with T2D and malnutrition or at risk of malnutrition who are prescribed a diabetes-specific ONS.
- Secondary Objectives
To assess changes in glycemic and metabolic control.
To evaluate the nutritional and functional impact of the ONS.
To analyze healthcare resource utilization and associated costs.
To estimate patient adherence, compliance, and satisfaction with the prescribed ONS.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with type 2 diabetes (T2D) or drug-induced diabetes
- •Patients at nutritional risk according to MUST or presenting malnutrition according to GLIM criteria.
- •Patients requiring a diabetes-specific oral nutritional supplement (ONS) that is high-calorie, high-protein, and contains soluble fiber in real-world clinical practice, and who have been prescribed such a supplement within the previous 7 days.
- •Patients able to provide informed consent and complete the study questionnaires.
排除标准
- •Patients participating in other studies or clinical trials related to malnutrition, or who, in the investigator's opinion, may alter the course of the study.
- •Patients currently receiving or expected to receive other types of nutritional interventions involving supplements (oral or otherwise) or non-conventional feeding methods (e.g., feeding tubes).
- •Patients with a history of metabolic/endocrine diseases (other than diabetes) or any other condition causing liver or kidney failure, defined as ALT > 3x ULN or eGFR < 30 ml/min/1.73 m², and according to the investigator's judgment.
- •Patients expected to undergo any surgical intervention or require hospitalization due to a condition unrelated to the study during the study period.
- •Patients with other conditions that, in the investigator's opinion, may interfere with adherence to the intervention or with study procedures.
研究组 & 干预措施
Patients with T2D or with drug-induced diabetes and malnutrition or at risk of it
结局指标
主要结局
Descriptive of study population
时间窗: Baseline visit (V1)
Descriptive information of the population at V1
次要结局
- Adherence with prescribed oral nutritional supplement (ONS)(From enrollment to end of treatment at 24 weeks)
- Percentage of patients with improvement in the nutritional status(From enrollment to end of treatment at 24 weeks)
- Associated cost at 6-month follow-up(From enrollment to end of treatment at 24 weeks)
- Percentage change of blood test parameters(From enrollment to end of treatment at 24 weeks)
- Change in functional status of participants over time(From enrollment to end of treatment at 24 weeks)
- Maximum prehensile strenght value(From enrollment to end of treatment at 24 weeks)
- 30" chair test(From enrollment to end of treatment at 24 weeks)
- Change in NutriQoL® quality-of-life score(From enrollment to end of treatment at 24 weeks)
- Patient satisfaction of the ONS product at 6 months(From enrollment to end of treatment at 24 weeks)
- Patient palatability of the ONS product at 6 months(From enrollment to end of treatment at 24 weeks)
- Health resource use(From enrollment to end of treatment at 24 weeks)
- Change in nutritional status(From enrollment to end of treatment at 24 weeks)
- Percentage change in BMI(From enrollment to end of treatment at 24 weeks)
- Impedancimetry values(From enrollment to end of treatment at 24 weeks)
研究者
研究点 (12)
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