Clinical trial NCT03766308: The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
Official title: The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: highland barley diet
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: from baseline to 12-week endpoint
Secondary outcomes:
measure: The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
timeFrame: 12 weeks
measure: blood glucose
timeFrame: 6 weeks and 12weeks
measure: Postprandial Blood Glucose
timeFrame: 6 weeks and 12weeks
measure: 7 point self-monitoring blood sugar
timeFrame: from baseline to 6 and 12 weeks
measure: blood lipid
timeFrame: from baseline to 6 and 12 weeks
measure: uric acid
timeFrame: from baseline to 6 and 12 weeks
measure: Insulin resistance index
timeFrame: 0weeks and 12weeks
measure: Beta cell function index of islet
timeFrame: 0weeks and 12weeks
measure: Change in body weight
timeFrame: from baseline to 12 weeks
measure: Change in Waist circumference
timeFrame: from baseline to 12 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology
state: Hubei
Study officials:
References: