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

• Sponsor: Xuefeng Yu (Other)
• Overall Status: Completed
• CT.gov ID: NCT03766308
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 38
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Dietary Supplement: Highland Barley Diet; Dietary Supplement: ADA diet	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Nov 1, 2017
• Actual Primary Completion Date: Oct 30, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Highland barley diet highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)	Dietary Supplement: Highland Barley Diet; Highland Barley Diet
Active Comparator: ADA diet ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)	Dietary Supplement: ADA diet; ADA diet

Outcome Measures

Primary Outcome Measures

1. HbA1c [from baseline to 12-week endpoint]

   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

1. The percentage of participants who achieved HbA1c ≤ 6.5% and < 7% [12 weeks]

   The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%

2. blood glucose [6 weeks and 12weeks]

   Fasting blood glucose

3. Postprandial Blood Glucose [6 weeks and 12weeks]

   Postprandial blood glucose

4. 7 point self-monitoring blood sugar [from baseline to 6 and 12 weeks]

   7 point self-monitoring blood sugar

5. blood lipid [from baseline to 6 and 12 weeks]

   blood lipid

6. uric acid [from baseline to 6 and 12 weeks]

   uric acid

7. Insulin resistance index [0weeks and 12weeks]

   Insulin resistance index

8. Beta cell function index of islet [0weeks and 12weeks]

   Beta cell function index of islet

9. Change in body weight [from baseline to 12 weeks]

   Change in body weight

10. Change in Waist circumference [from baseline to 12 weeks]

    Change in Waist circumference

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology	Wuhan	Hubei	China

Sponsors and Collaborators

• Xuefeng Yu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xuefeng Yu, Director of Department of Endocrinology, Huazhong University of Science and Technology
• ClinicalTrials.gov Identifier: NCT03766308
• Other Study ID Numbers: TJ-NFM-0001
• First Posted: Dec 6, 2018
• Last Update Posted: Sep 1, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xuefeng Yu, Director of Department of Endocrinology, Huazhong University of Science and Technology: highland barley diet
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 1, 2021