The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus

Detailed Description
-----------------
The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus. Approximately 40 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: highland barley diet + metformin; or +common diet metformin. Study treatment will continue for 12 weeks. The primary efficacy measure is the change in HbA1c at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 4-week run-in period (period B) and a 12-week treatment period (period C).

Official Title
-----------------
The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: Highland Barley Diet
* Dietary Supplement: ADA diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 BMI ≥ 23 and ≤ 35 kg/m2 Exclusion Criteria: 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 Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male Serious chronic gastrointestinal diseases Edema Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg White blood count (WBC) < 4.0×109/L or platelet count (PLT) < 90×109/L，or definite anemia (Hb：< 120g/L for male, < 110g/L for female), or other hematological diseases Endocrine system diseases, such as hyperthyroidism and hypercortisolism Experimental drug allergy or frequent hypoglycemia Psychiatric disorders, drug or other substance abuse Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy Stressful situations such as surgery, serious trauma and so on Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease Combined use of drugs effecting glucose metabolism such as glucocorticoid Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Highland barley diet<br>highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily) | Dietary Supplement: Highland Barley Diet<br>* Highland Barley Diet<br>|
| Active Comparator: ADA diet<br>ADA diet + Metformin sustained-release tablets(500mg, thrice-daily) | Dietary Supplement: ADA diet<br>* ADA diet<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | In the newly diagnosed type 2 diabetic patients, the absolute value of glycosylated hemoglobin from baseline to 12-week endpoints was compared between groups in the qingke diet group and the normal diet group. | from baseline to 12-week endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants who achieved HbA1c ≤ 6.5% and < 7% | The percentage of participants who achieved HbA1c ≤ 6.5% and < 7% | 12 weeks | 
| blood glucose | Fasting blood glucose | 6 weeks and 12weeks | 
| Postprandial Blood Glucose | Postprandial blood glucose | 6 weeks and 12weeks | 
| 7 point self-monitoring blood sugar | 7 point self-monitoring blood sugar | from baseline to 6 and 12 weeks | 
| blood lipid | blood lipid | from baseline to 6 and 12 weeks | 
| uric acid | uric acid | from baseline to 6 and 12 weeks | 
| Insulin resistance index | Insulin resistance index | 0weeks and 12weeks | 
| Beta cell function index of islet | Beta cell function index of islet | 0weeks and 12weeks | 
| Change in body weight | Change in body weight | from baseline to 12 weeks | 
| Change in Waist circumference | Change in Waist circumference | from baseline to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
highland barley diet