NCT07329231 Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes
| NCT ID | NCT07329231 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qilu Hospital of Shandong University |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-01-10 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-01-10 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria： 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07329231 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 70 Years, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07329231 currently recruiting?
Yes, NCT07329231 is actively recruiting participants. Contact the research team at tangkx_ql@hotmail.com for enrollment information.
Where is the NCT07329231 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07329231 clinical trial?
NCT07329231 is sponsored by Qilu Hospital of Shandong University. The trial plans to enroll 60 participants.
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