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

Huazhong University of Science and Technology

Status

Withdrawn

Conditions

Type1 Diabetes Mellitus

Treatments

Dietary Supplement: Highland Barley Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03766334

TJ-T1DM-CGM-001

Details and patient eligibility

About

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.

Full description

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

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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