Actively Recruiting

Phase Not Applicable
Age: 20Years - 70Years
All Genders
NCT07329231

Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes

Led by Qilu Hospital of Shandong University · Updated on 2026-01-09

60

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Quinoa Improves Glycolipid Metabolism and Glucose Fluctuation Based on β-Cell Function in Early-stage Type 2 Diabetes

Who Can Participate

Age: 20Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes mellitus using 1999 WHO criteria
  • Disease duration less than 5 years
  • HbA1c between 6.5% and 10%
  • No history of insulin therapy
  • Age between 20 and 70 years
Not Eligible

You will not qualify if you...

  • Acute diabetic complications such as diabetic ketoacidosis
  • Severe acute or chronic diseases affecting liver, kidneys, heart, brain, or digestive system
  • Acute infectious diseases
  • Pregnancy or plans for pregnancy soon
  • Allergies to quinoa or bean products
  • Participation in other dietary or drug clinical trials within the past 3 months
  • Gastrointestinal diseases within 2 weeks before enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Qilu Hospital of Shandong University

Jinan, Shandong, China, 250000

Actively Recruiting

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Research Team

X

Xiao K Tang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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