The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

Study Overview
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Brief Summary
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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.

Official Title
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The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

Conditions
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Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: Cyclocarya paliurus extract
* Dietary Supplement: Cyclocarya paliurus compounds
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be divided randomly into three groups，among which the intervention will start and end simultaneously.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>corn starch；capsule，2 g/day，2 times/day；3 months | Dietary Supplement: placebo<br>* The participants are divided randomly into three groups，one of which are asked to take placebo for three months .<br>|
| Experimental: Cyclocarya paliurus extract<br>aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months | Dietary Supplement: Cyclocarya paliurus extract<br>* The participants are divided randomly into three groups，one of which are asked to Cyclocarya paliurus extract for three months .<br>|
| Experimental: Cyclocarya paliurus compounds<br>mixed aqueous extract of Cyclocarya paliurus and other traditional Chinese herbal medicines including Astragalus propinquus Schischkin，Dioscorea oppositifolia L.，Dendrobium nobile Lindl.，Salvia miltiorrhiza Bge. and Inulin；capsule，2 g/day，2 times/day；3 months | Dietary Supplement: Cyclocarya paliurus compounds<br>* The participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of FPG | fasting plasma glucose | at 0 week，4th week and 12th week in the intervention period | 
| changes of HbA1c | glycated hemoglobin | at 0 week，4th week and 12th week in the intervention period | 
| changes of fasting insulin |  | at 0 week，4th week and 12th week in the intervention period | 
| changes of OGTT | oral glucose tolerance test | at 0 week，4th week and 12th week in the intervention period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of blood lipids | total cholesterol，high density lipoprotein cholesterol，low density lipoprotein cholesterol，triglyceride | at 0 week，4th week and 12th week in the intervention period | 
| changes of gut microbiota | 16s RNA sequencing | at 0 week，4th week and 12th week in the intervention period | 
| changes of short chain fatty acids | metabolites of microbiota in feces | at 0 week，4th week and 12th week in the intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclocarya paliurus extract, hyperglycemia, pre-diabetes and diabetes