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

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

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Highland Barley Diet; Dietary supplement: ADA diet

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

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: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%	The percentage of participants who achieved HbA1c ≤ 6.5% and < 7%	12 weeks
blood glucose	Fasting blood glucose	6 weeks and 12weeks
Postprandial Blood Glucose	Postprandial blood glucose	6 weeks and 12weeks
7 point self-monitoring blood sugar	7 point self-monitoring blood sugar	from baseline to 6 and 12 weeks
blood lipid	blood lipid	from baseline to 6 and 12 weeks
uric acid	uric acid	from baseline to 6 and 12 weeks
Insulin resistance index	Insulin resistance index	0weeks and 12weeks
Beta cell function index of islet	Beta cell function index of islet	0weeks and 12weeks
Change in body weight	Change in body weight	from baseline to 12 weeks
Change in Waist circumference	Change in Waist circumference	from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Xuefeng Yu

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: highland barley diet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: TJ-NFM-0001

Drug and device information, study documents

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