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

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.

Study Overview

• Status: Withdrawn
• Conditions: Type1 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Highland Barley Diet

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

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuefeng Yu, doctor; Phone Number: +86-13986070673; Email: xfyu188@163.com
• Study Contact Backup: Name: LI Liu; Phone Number: +86-18202755862; Email: 287715963@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetes Diet+Highland Barley Diet; Diabetes Diet+Highland Barley Diet(20g, thrice-daily)	Dietary supplement: Highland Barley Diet; Highland Barley Diet(20g, thrice-daily)
No Intervention: Diabetes Diet; only Diabetes Diet

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: xuefeng Yu, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2018
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Glucose variability; Highland Barley Diet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: TJ-T1DM-CGM-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No