Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes
报名条件（概要）
- 年龄：20 Years – 70 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
Quinoa-based foods included three varieties: quinoa noodles (80 g per bag; the ingredients included quinoa powder, red bean powder, black wheat powder, black mung bean powder, and edible salt, with quinoa powder comprising 15% of the total produced by Shandong Tangren Duoyi Biotechnology Company), blended powder (15 g per bag; the ingredients included quinoa, rye wheat, black mung beans, adzuki beans, black sesame seeds, chickpeas, konjac flour, and mogroside, with quinoa flour comprising 20% of the total produced by Shandong Tangren Duoyi Biotechnology Company), and cookies (24 g per bag; quinoa, rye, adzuki beans, black sesame seeds, vegetable oil, and salt, with quinoa comprising 20% of the total produced by Shandong Tangren Duoyi Biotechnology Company). These products serve as substitutes for the common starchy staples, soups, porridge, and snacks typically consumed by T2DM patients. This substitution did not alter patients' daily eating habits; rather, it simply replaced tradition
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
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.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Xiao K Tangtangkx_ql@hotmail.com008618560083053
中国／港澳台研究中心
- Qilu Hospital of Shandong UniversityJinan，Shandong，China
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes ClinicalTrials.gov Identifier: NCT07329231 Sponsor: Qilu Hospital of Shandong University Investigational product: Quinoa-based foods About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes 试验编号：NCT07329231 申办方：Qilu Hospital of Shandong University 研究药物：Quinoa-based foods 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
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