Hyperglycemia
Conditions
Keywords
Cyclocarya paliurus extract, hyperglycemia, pre-diabetes and diabetes
Brief summary
This is a randomized double-blind controlled trial，aiming to investigate the hypoglycemic effect of Cyclocarya paliurus extract and Cyclocarya paliurus compounds on hyperglycemic populations without modifying their original treatment plans.
Interventions
DIETARY_SUPPLEMENTCyclocarya paliurus extract
The participants are divided randomly into three groups，one of which are asked to Cyclocarya paliurus extract for three months .
DIETARY_SUPPLEMENTCyclocarya paliurus compounds
The participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months .
DIETARY_SUPPLEMENTplacebo
The participants are divided randomly into three groups，one of which are asked to take placebo for three months .
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The allocation of three groups is completed by the primary researcher,and unknown to participants and other reachers. It is the same in the size,color,shape and taste of capsules administrated by three groups.
Intervention model description
Participants will be divided randomly into three groups，among which the intervention will start and end simultaneously.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* pre-diabetic or type 2 diabetic patients who are treated with only one oral antidiabetic agent and whose fasting plasma glucose is lower than 8.4 mmol; * age:20-65 years; * BMI :20-35kg/m2.
Exclusion criteria
* type 1 diabetic patients; * type 2 diabetic patients with insulin treatment； * pregnant or lactating women； * adverse effect on intervention； * acute or chronic inflammatory conditions; * severe hepatic,kidney or other complications; * other situations ineligible to intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of FPG | at 0 week，4th week and 12th week in the intervention period | fasting plasma glucose |
| changes of HbA1c | at 0 week，4th week and 12th week in the intervention period | glycated hemoglobin |
| changes of fasting insulin | at 0 week，4th week and 12th week in the intervention period | — |
| changes of OGTT | at 0 week，4th week and 12th week in the intervention period | oral glucose tolerance test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes of blood lipids | at 0 week，4th week and 12th week in the intervention period | total cholesterol，high density lipoprotein cholesterol，low density lipoprotein cholesterol，triglyceride |
| changes of gut microbiota | at 0 week，4th week and 12th week in the intervention period | 16s RNA sequencing |
| changes of short chain fatty acids | at 0 week，4th week and 12th week in the intervention period | metabolites of microbiota in feces |
Countries
China
Contacts
Primary ContactLiegang Liu, PhD
Backup ContactHongjie Liu, master
Outcome results
None listed