Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus
Reason given: Project closure
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Trial details
- Who runs it
- Huazhong University of Science and Technology
- Trial code
- NCT03766334
- Record updated
- 18 March 2024
- Original description
Approximately 80 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms:diabetes diet+highland barley diet; or diabetes diet.Read full original descriptionShow less
Approximately 80 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms:diabetes diet+highland barley diet; or diabetes diet.
Study treatment will continue for 12 weeks. The primary efficacy measure is the change in MAGE from continuous glucose monitoring system at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 8-day run-in period (period B) and a 12-week treatment period (period C). Continuous glucose monitoring system will be used in baseline and endpoint.
Inclusion: type 1 diabetes patients with disease duration more than one year; HbA1c ≥7.0 % and < 11.0 %; Men and women (non-pregnant and using a medically approved birthcontrol method) aged ≥ 18 and ≤ 65 years; BMI ≥ 18 and ≤ 26 kg/m2.
Exclusion: Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy; Stressful situations such as surgery, serious trauma and so on; Type 2 diabetes or other specific types of diabetes; 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; Endocrine system diseases, such as hyperthyroidism and hypercortisolism; Experimental drug allergy or frequent hypoglycemia; Psychiatric disorders, drug or other substance abuse; Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease; 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; 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; 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; Pregnancy, preparation for pregnancy, lactation and women of childbearing age incapable of effective contraception methods; Uncooperative subject because of various reasons; Edema; Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg.