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

Type1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03766334
• Other study ID #: TJ-T1DM-CGM-001
• Status: Withdrawn
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Dietary Supplement:
• Highland Barley Diet
Highland Barley Diet(20g, thrice-daily)

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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