The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766308
• Other study ID #: TJ-NFM-0001
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Provision of informed consent

2. Type 2 diabetic patients (new diagnose )

3. HbA1c =7.0 % and < 9.0 % (HbA1c > 7.0 % and = 8.0% at randomization)

4. Men and women (non-pregnant and using a medically approved birth-control method) aged = 18 and = 70 years

5. BMI = 23 and = 35 kg/m2

Exclusion Criteria:

1. Type 1 diabetes or other specific types of diabetes

2. Pregnancy, preparation for pregnancy, lactation and women of child-bearing 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 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Highland Barley Diet
Highland Barley Diet
• ADA diet
ADA diet

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Xuefeng Yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from baseline to 12-week endpoint
Secondary	The percentage of participants who achieved HbA1c = 6.5% and < 7%	The percentage of participants who achieved HbA1c = 6.5% and < 7%	12 weeks
Secondary	blood glucose	Fasting blood glucose	6 weeks and 12weeks
Secondary	Postprandial Blood Glucose	Postprandial blood glucose	6 weeks and 12weeks
Secondary	7 point self-monitoring blood sugar	7 point self-monitoring blood sugar	from baseline to 6 and 12 weeks
Secondary	blood lipid	blood lipid	from baseline to 6 and 12 weeks
Secondary	uric acid	uric acid	from baseline to 6 and 12 weeks
Secondary	Insulin resistance index	Insulin resistance index	0weeks and 12weeks
Secondary	Beta cell function index of islet	Beta cell function index of islet	0weeks and 12weeks
Secondary	Change in body weight	Change in body weight	from baseline to 12 weeks
Secondary	Change in Waist circumference	Change in Waist circumference	from baseline to 12 weeks