Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, randomized, open-label comparison of the effects and safety of barley meal plus diabetes diet on blood glucose fluctuations in patients with type 1 diabetes (T1DM) using multiple daily insulin injections (MDI). , parallel test. About 80 patients with T1DM were enrolled in the preliminary trial. During the lead-in period, no interventions were given to the patient's diet from day 1 to day 4, and diabetes diet education and guidance were given from day 5 to day 8, depending on the patient's blood glucose and diet. Personalization of habits, weights, and activities, etc., establish a diabetes diet. At the end of the lead-in period, patients were randomly divided into two treatment groups according to the ratio of 1:1: Observation group: Diabetes diet + barley diet. (The barley meal group diet was formulated according to the diabetes diet, but each meal was replaced with 20g barley nutrition powder and other calories instead of part of the diet. In the control group: Diabetes diet; dietary treatment after randomization will continue for 12 weeks. From the induction period to the treatment period 6 days, treatment period 10-12 weeks

Official Title
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Efficacy and Safety of Highland Barley Diet on Glucose Variability in Patients With Type 1 Diabetes Mellitus

Conditions
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Type1 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Highland Barley Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Type 2 diabetes or other specific types of diabetes Pregnancy, preparation for pregnancy, lactation and women of childbearing 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 Edema 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Diet+Highland Barley Diet<br>Diabetes Diet+Highland Barley Diet(20g, thrice-daily) | Dietary Supplement: Highland Barley Diet<br>* Highland Barley Diet(20g, thrice-daily)<br>|
| No Intervention: Diabetes Diet<br>only Diabetes Diet | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average blood glucose fluctuations at endpoint and baseline | Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose variability in insufficient control patients with type 1 diabetes. | from baseline to 12-week endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin(endpoint)-Glycated hemoglobin(baseline) | Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose control in patients with type 1 diabetes. | from baseline to 12-week endpoint | 
| insulin dose(endpoint)-insulin dose(baseline) | Objective to investigate the effect of combination diabetes diet and highland barley diet on insulin dose in patients with type 1 diabetes. | from baseline to 12-week endpoint | 
| Quality of life assessment scale SF-36(endpoint)-Quality of life assessment scale SF-36(baseline) | Objective to investigate the effect of combination diabetes diet and highland barley diet on life quality in patients with type 1 diabetes. | from baseline to 12-week endpoint | 
| Body mass index(endpoint)-Body mass index(baseline) | Objective to investigate the effect of combination diabetes diet and highland barley diet on BMI in patients with type 1 diabetes. | from baseline to 12-week endpoint | 
| beta-cell function at endpoint and baseline | Objective to investigate the effect of combination diabetes diet and highland barley diet on beta-cell function in patients with type 1 diabetes. | from baseline to 12-week endpoint | 
| Waist circumference(endpoint)-Waist circumference(baseline) | Objective to investigate the effect of combination diabetes diet and highland barley diet on waist circumference in patients with type 1 diabetes. | from baseline to 12-week endpoint | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Highland Barley Diet, Glucose variability