Back to resultsThe Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Highland Barley Diet
ADA diet
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring highland barley diet
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent
- Type 2 diabetic patients （new diagnose ）
- HbA1c ≥7.0 % and < 9.0 % (HbA1c > 7.0 % and ≤ 8.0% at randomization)
- Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
- BMI ≥ 23 and ≤ 35 kg/m2
Exclusion Criteria:
- Type 1 diabetes or other specific types of diabetes
- Pregnancy, preparation for pregnancy, lactation and women of child-bearing 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 technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Highland barley diet
ADA diet
Arm Description
highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)
ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)
Outcomes
Primary Outcome Measures
HbA1c
In the newly diagnosed type 2 diabetic patients, the absolute value of glycosylated hemoglobin from baseline to 12-week endpoints was compared between groups in the qingke diet group and the normal diet group.
Secondary Outcome Measures
The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
blood glucose
Fasting blood glucose
Postprandial Blood Glucose
Postprandial blood glucose
7 point self-monitoring blood sugar
7 point self-monitoring blood sugar
blood lipid
blood lipid
uric acid
uric acid
Insulin resistance index
Insulin resistance index
Beta cell function index of islet
Beta cell function index of islet
Change in body weight
Change in body weight
Change in Waist circumference
Change in Waist circumference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03766308
Brief Title
The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
Official Title
The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuefeng Yu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus
Detailed Description
The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus.
Approximately 40 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: highland barley diet + metformin; or +common diet metformin.
Study treatment will continue for 12 weeks. The primary efficacy measure is the change in HbA1c at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 4-week run-in period (period B) and a 12-week treatment period (period C).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
highland barley diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Highland barley diet
Arm Type
Experimental
Arm Description
highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)
Arm Title
ADA diet
Arm Type
Active Comparator
Arm Description
ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)
Intervention Type
Dietary Supplement
Intervention Name(s)
Highland Barley Diet
Intervention Description
Highland Barley Diet
Intervention Type
Dietary Supplement
Intervention Name(s)
ADA diet
Intervention Description
ADA diet
Primary Outcome Measure Information:
Title
HbA1c
Description
In the newly diagnosed type 2 diabetic patients, the absolute value of glycosylated hemoglobin from baseline to 12-week endpoints was compared between groups in the qingke diet group and the normal diet group.
Time Frame
from baseline to 12-week endpoint
Secondary Outcome Measure Information:
Title
The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
Description
The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%
Time Frame
12 weeks
Title
blood glucose
Description
Fasting blood glucose
Time Frame
6 weeks and 12weeks
Title
Postprandial Blood Glucose
Description
Postprandial blood glucose
Time Frame
6 weeks and 12weeks
Title
7 point self-monitoring blood sugar
Description
7 point self-monitoring blood sugar
Time Frame
from baseline to 6 and 12 weeks
Title
blood lipid
Description
blood lipid
Time Frame
from baseline to 6 and 12 weeks
Title
uric acid
Description
uric acid
Time Frame
from baseline to 6 and 12 weeks
Title
Insulin resistance index
Description
Insulin resistance index
Time Frame
0weeks and 12weeks
Title
Beta cell function index of islet
Description
Beta cell function index of islet
Time Frame
0weeks and 12weeks
Title
Change in body weight
Description
Change in body weight
Time Frame
from baseline to 12 weeks
Title
Change in Waist circumference
Description
Change in Waist circumference
Time Frame
from baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent
Type 2 diabetic patients （new diagnose ）
HbA1c ≥7.0 % and < 9.0 % (HbA1c > 7.0 % and ≤ 8.0% at randomization)
Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
BMI ≥ 23 and ≤ 35 kg/m2
Exclusion Criteria:
Type 1 diabetes or other specific types of diabetes
Pregnancy, preparation for pregnancy, lactation and women of child-bearing 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
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology
City
Wuhan
State/Province
Hubei
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
We'll reach out to this number within 24 hrs