Completed

Highland Barley Diet and Metformin for Type 2 Diabetes Blood Glucose Control

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Study Aim

This study aims to compare the effectiveness of a Highland Barley diet and Metformin in controlling blood glucose levels in newly diagnosed type 2 diabetes patients, by measuring the change in glycosylated hemoglobin (HbA1c) over a 12-week period.

What is being tested

Highland Barley Diet

+ ADA diet

Dietary Supplement
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 75 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2017
See protocol details

Summary

Principal SponsorXuefeng Yu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2017

Actual date on which the first participant was enrolled.

This study explores how a highland barley diet impacts blood sugar levels in individuals with type 2 diabetes. The research aims to enroll around 40 patients from China, focusing on those newly diagnosed with type 2 diabetes. The importance of this study lies in its potential to uncover dietary strategies that could help manage blood sugar levels more effectively in diabetes patients, thereby improving their overall health and quality of life. Participants will be randomly assigned to one of two treatment groups. One group will follow a highland barley diet along with metformin, a common diabetes medication, while the other group will follow a regular diet along with metformin. The study will last for 12 weeks, with a primary focus on measuring changes in HbA1c, a key indicator of average blood sugar levels over time. The study is structured into three periods: a 1-week screening, a 4-week run-in period, and a 12-week treatment period.

Official TitleThe Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
NCT03766308
Principal SponsorXuefeng Yu
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate
Provision of informed consent
Type 2 diabetic patients （new diagnose ）
HbA1c ≥7.0 % and < 9.0 % (HbA1c > 7.0 % and ≤ 8.0% at randomization)
Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
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17 exclusion criteria prevent from participating
Type 1 diabetes or other specific types of diabetes
Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods
Uncooperative subject because of various reasons
Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) > twice the upper limits of normal
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)

Group II

Active Comparator
ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology

Wuhan, ChinaOpen Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology in Google Maps
CompletedOne Study Center