The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT03766308
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-11-01
2020-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Highland barley diet
highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)
Highland Barley Diet
Highland Barley Diet
ADA diet
ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)
ADA diet
ADA diet
Interventions
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Highland Barley Diet
Highland Barley Diet
ADA diet
ADA diet
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Xuefeng Yu
OTHER
Responsible Party
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Xuefeng Yu
Director of Department of Endocrinology
Locations
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Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology
Wuhan, Hubei, China
Countries
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Other Identifiers
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TJ-NFM-0001
Identifier Type: -
Identifier Source: org_study_id
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