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

NCT ID: NCT03766334

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2023-12-31

Brief Summary

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

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

Conditions

Type1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diabetes Diet+Highland Barley Diet

Diabetes Diet+Highland Barley Diet(20g, thrice-daily)

Group Type: EXPERIMENTAL

Highland Barley Diet

Intervention Type: DIETARY_SUPPLEMENT

Highland Barley Diet(20g, thrice-daily)

Diabetes Diet

only Diabetes Diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Highland Barley Diet

Highland Barley Diet(20g, thrice-daily)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. type 1 diabetes patients with disease duration more than one year

2. HbA1c ≥7.0 % and < 11.0 %

3. Men and women (non-pregnant and using a medically approved birthcontrol method) aged ≥ 18 and ≤ 65 years

4. BMI ≥ 18 and ≤ 26 kg/m2

Exclusion Criteria

1. Type 2 diabetes or other specific types of diabetes

2. Pregnancy, preparation for pregnancy, lactation and women of childbearing 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xuefeng Yu

Chief of Department of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xuefeng Yu

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology

Wuhan, Hubei, China

Countries

China

Other Identifiers

TJ-T1DM-CGM-001

Identifier Type: -

Identifier Source: org_study_id