Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change in HbA1c levels
研究概览
简要总结
This randomized controlled trial investigates the effectiveness of AI-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing Type 2 diabetes (T2D). The study includes 160 participants with T2D, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the AI-guided group (prescriptions determined by GenAIS, an AI system by Triangel Scientific). The primary objective is to compare the reduction in HbA1c levels between the two groups over 6 months. Secondary outcomes include changes in fasting glucose, lipid profiles, body weight, BMI, hsCRP levels, and adherence to the dietary supplement regimen. The AI system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and 75 years.
- •Diagnosed with Type 2 diabetes (HbA1c between 7.0% and 10.0%).
- •Stable anti-diabetic medication regimen for at least 3 months prior to the study.
- •Willingness to provide genetic and metabolic data.
排除标准
- •Type 1 diabetes or other specific types of diabetes.
- •Significant renal, hepatic, or cardiovascular diseases.
- •Use of dietary supplements that affect glucose metabolism within the last 3 months.
- •Pregnancy or breastfeeding
结局指标
主要结局
Change in HbA1c levels
时间窗: 180 days
次要结局
- Percent change in body weight(180 days)
- Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)(180 days)
- Percent change in high-sensitivity C-reactive protein(180 days)
- Percent change in Body mass index (BMI)(180 days)
- Percentage of participants using antihypertensive medications (%)(180 days)
- Percent change in cholesterol(180 days)
- Percent change in triglycerides(180 days)
- changes in physical activity levels (hours/week)(180 days)
- Percentage of participants using lipid-lowering medications (%).(180 days)
- Percent change in fasting venous blood glucose levels.(180 days)
- Percent change in HDL-C,(180 days)
- Percent change in LDL-C(180 days)
- Incidence of any adverse effects related to supplements(180 days)
- Percentage of participants using antihypertensive medications (%).(180 days)
- fasting insulin levels change (mU/mL)(180 days)
- Waist Circumference (cm) change(180 days)
- microalbuminuria (%) difference(180 days)