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

Primary Purpose

Type1 Diabetes Mellitus

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Highland Barley Diet

About this trial

This is an interventional treatment trial for Type1 Diabetes Mellitus focused on measuring Highland Barley Diet, Glucose variability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diabetes Diet+Highland Barley Diet

Diabetes Diet

Arm Description

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

only Diabetes Diet

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03766334

First Posted

July 2, 2018

Last Updated

August 30, 2021

Sponsor

Huazhong University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT03766334

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 5, 2018 (Actual)

Primary Completion Date

October 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type1 Diabetes Mellitus

Keywords

Highland Barley Diet, Glucose variability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diabetes Diet+Highland Barley Diet

Arm Type

Experimental

Arm Description

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

Arm Title

Diabetes Diet

Arm Type

No Intervention

Arm Description

only Diabetes Diet

Intervention Type

Dietary Supplement

Intervention Name(s)

Highland Barley Diet

Intervention Description

Highland Barley Diet(20g, thrice-daily)

Primary Outcome Measure Information:

Title

Average blood glucose fluctuations at endpoint and baseline

Description

Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose variability in insufficient control patients with type 1 diabetes.

Time Frame

from baseline to 12-week endpoint

Secondary Outcome Measure Information:

Title

Glycated hemoglobin(endpoint)-Glycated hemoglobin(baseline)

Description

Objective to investigate the effect of combination diabetes diet and highland barley diet on glucose control in patients with type 1 diabetes.

Time Frame

from baseline to 12-week endpoint

Title

insulin dose(endpoint)-insulin dose(baseline)

Description

Objective to investigate the effect of combination diabetes diet and highland barley diet on insulin dose in patients with type 1 diabetes.

Time Frame

from baseline to 12-week endpoint

Title

Quality of life assessment scale SF-36(endpoint)-Quality of life assessment scale SF-36(baseline)

Description

Objective to investigate the effect of combination diabetes diet and highland barley diet on life quality in patients with type 1 diabetes.

Time Frame

from baseline to 12-week endpoint

Title

Body mass index(endpoint)-Body mass index(baseline)

Description

Objective to investigate the effect of combination diabetes diet and highland barley diet on BMI in patients with type 1 diabetes.

Time Frame

from baseline to 12-week endpoint

Title

beta-cell function at endpoint and baseline

Description

Objective to investigate the effect of combination diabetes diet and highland barley diet on beta-cell function in patients with type 1 diabetes.

Time Frame

from baseline to 12-week endpoint

Title

Waist circumference(endpoint)-Waist circumference(baseline)

Description

Objective to investigate the effect of combination diabetes diet and highland barley diet on waist circumference in patients with type 1 diabetes.

Time Frame

from baseline to 12-week endpoint

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xuefeng Yu, doctor

Phone

+86-13986070673

xfyu188@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

LI Liu

Phone

+86-18202755862

287715963@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

xuefeng Yu

Organizational Affiliation

Tongji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xi Chen, doctor

Phone

86+13667217301

amazingamycx@163.com

12. IPD Sharing Statement

Plan to Share IPD

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

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