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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: ADA diet; Dietary Supplement: Highland Barley Diet

• Registration Number: NCT03766308
• Lead Sponsor: Xuefeng Yu

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).

Study Timeline

• Study First Submitted: 2017-10-29
• Study Start: 2017-11-01
• Study First Submitted QC: 2018-12-04
• Study First Posted: 2018-12-06
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADA diet	ADA diet	ADA diet + Metformin sustained-release tablets(500mg, thrice-daily)
Highland barley diet	Highland Barley Diet	highland barley diet(20g, thrice-daily) +Metformin sustained-release tablets(500mg, thrice-daily)

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and technology; 🇨🇳 Wuhan, Hubei, China