Type 2 Diabetes Mellitus
Conditions
Keywords
highland barley diet
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).
Interventions
DIETARY_SUPPLEMENTHighland Barley Diet
Highland Barley Diet
DIETARY_SUPPLEMENTADA diet
ADA diet
Sponsors
Xuefeng Yu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent 2. Type 2 diabetic patients （new diagnose ） 3. HbA1c ≥7.0 % and \< 9.0 % (HbA1c \> 7.0 % and ≤ 8.0% at randomization) 4. Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years 5. BMI ≥ 23 and ≤ 35 kg/m2
Exclusion criteria
1. Type 1 diabetes or other specific types of diabetes 2. Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods 3. Uncooperative subject because of various reasons 4. Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) \> twice the upper limits of normal 5. Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male 6. Serious chronic gastrointestinal diseases 7. Edema 8. Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction 9. Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg 10. 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 11. Endocrine system diseases, such as hyperthyroidism and hypercortisolism 12. Experimental drug allergy or frequent hypoglycemia 13. Psychiatric disorders, drug or other substance abuse 14. Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy 15. Stressful situations such as surgery, serious trauma and so on 16. Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease 17. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | from baseline to 12-week endpoint | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 7 point self-monitoring blood sugar | from baseline to 6 and 12 weeks | 7 point self-monitoring blood sugar |
| blood lipid | from baseline to 6 and 12 weeks | blood lipid |
| uric acid | from baseline to 6 and 12 weeks | uric acid |
| Insulin resistance index | 0weeks and 12weeks | Insulin resistance index |
| Change in Waist circumference | from baseline to 12 weeks | Change in Waist circumference |
| Change in body weight | from baseline to 12 weeks | Change in body weight |
| The percentage of participants who achieved HbA1c ≤ 6.5% and < 7% | 12 weeks | The percentage of participants who achieved HbA1c ≤ 6.5% and \< 7% |
| blood glucose | 6 weeks and 12weeks | Fasting blood glucose |
| Postprandial Blood Glucose | 6 weeks and 12weeks | Postprandial blood glucose |
| Beta cell function index of islet | 0weeks and 12weeks | Beta cell function index of islet |
Countries
China
Outcome results
None listed