Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes
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
- Glucose variability (MAGE) assessed by continuous glucose monitoring
研究概览
简要总结
The goal of this clinical trial is to explore whether quinoa diet can improve glycolipid metabolism and glucose fluctuations in patients with early-stage type 2 diabetes mellitus (T2DM) and observe its impact on islet β-cell function and insulin resistance in patients with early-stage T2DM (diagnosed according to the 1999 WHO criteria, disease duration <5 years, HbA1c 6.5%-10%, no history of insulin therapy, aged 20-70 years).
The main question it aims to answer is:
Can quinoa diet reduce blood glucose (fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin), improve lipid metabolism (cholesterol, triglycerides), and stabilize glucose fluctuations (time in range, time above range) in patients with early-stage T2DM? Does quinoa diet improve islet β-cell function (HOMA-β) and insulin resistance (HOMA-IR), and reduce the need for oral hypoglycemic medications? Comparison group: Researchers will compare the quinoa diet (QD) group (replacing traditional starchy foods with quinoa products) vs. the regular diet (RD) group (conventional diet) to see if quinoa diet demonstrates better metabolic improvement and medication reduction effects.
Participants will:
Be randomly assigned to the QD group or RD group. Undergo oral glucose tolerance tests (OGTTs) and continuous glucose monitoring (cGMS) at baseline and after the intervention.
The QD group will consume quinoa-based foods (noodles, blended powder, cookies) as substitutes for staple foods, beverages, and snacks for 14 weeks, documenting daily intake in a record book.
Both groups will receive standardized dietary and exercise education, with monthly follow-ups for food distribution and data collection.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed according to the 1999 WHO diagnostic criteria for T2DM with a duration of less than 5 years HbA1c levels between 6.5% and 10% no history of insulin therapy age between 20 and 70 years.
排除标准
- •acute complications of diabetes, such as diabetic ketoacidosis severe acute or chronic conditions affecting the liver, kidneys, heart, cerebrovascular system, gastrointestinal tract, or acute infectious diseases pregnancy or plans for pregnancy soon allergies to quinoa or bean products participation in other dietary interventions or drug clinical trials within the past three months gastrointestinal diseases within two weeks prior to enrolment.
结局指标
主要结局
Glucose variability (MAGE) assessed by continuous glucose monitoring
时间窗: From registration to the end of the 14-week treatment
Change from baseline to week 14 in Mean Amplitude of Glycemic Excursions (MAGE) calculated from 72-hour continuous glucose monitoring data.
次要结局
未报告次要终点
研究者
kuanxiao Tang
chief physician
Qilu Hospital of Shandong University