NCT07271043招募中不适用
Evaluating the Efficacy of High-Protein Diabetes Specific Formula (HP-DSF) on Body Composition in Overweight/Obese Patients With Type 2 Diabetes Treated With Incretin Mimetic Drugs
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in lean muscle mass from baseline
研究概览
简要总结
A randomized clinical study to assess the efficacy of a high-protein diabetes specific formula (HPDSF) on lean muscle mass in overweight and obese patients with type 2 diabetes who are initiating treatment with incretin-mimetic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 18-75 years of age
- •Subject was diagnosed with type 2 diabetes at least 3 months prior to screening
- •Subject is about to start treatment with an IMD, a GLP-1 receptor agonist (RA) alone or a dual GLP-1/GIP RA. These treatments include either semaglutide (Ozempic®, Wegovy®), tirzepatide (Mounjaro®, Zepbound®), or dulaglutide (Trulicity®)
- •Body mass index (BMI) is ≥ 25 kg/m2
排除标准
- •Subject has type 1 diabetes mellitus
- •Subject with estimated glomerular filtration rate <60 milliliters/minute/1.73 m²,
- •Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
- •History of acute kidney injury (AKI) during the 6 months prior to screening g.
- •Intolerance or allergy to HP-DSF shake or to any of its ingredients
- •Women who are pregnant or lactating or expect to be pregnant or lactating during the study period.
- •Women of childbearing potential who are not using highly effective contraceptive methods.
研究组 & 干预措施
Participants in this control group will follow the regular standard of diabetes care
No Intervention
结局指标
主要结局
Change in lean muscle mass from baseline
时间窗: Endpoints will be analyzed at three months and six months.
次要结局
未报告次要终点
研究者
研究点 (1)
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