The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
结局指标
主要结局
HbA1c
时间窗: 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.
次要结局
- Change in body weight(from baseline to 12 weeks)
- The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%(12 weeks)
- blood glucose(6 weeks and 12weeks)
- blood lipid(from baseline to 6 and 12 weeks)
- Postprandial Blood Glucose(6 weeks and 12weeks)
- Beta cell function index of islet(0weeks and 12weeks)
- Change in Waist circumference(from baseline to 12 weeks)
- uric acid(from baseline to 6 and 12 weeks)
- 7 point self-monitoring blood sugar(from baseline to 6 and 12 weeks)
- Insulin resistance index(0weeks and 12weeks)
研究者
Xuefeng Yu
Director of Department of Endocrinology
Huazhong University of Science and Technology