Back to resultsThe Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
Primary Purpose
Hyperglycemia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cyclocarya paliurus extract
Cyclocarya paliurus compounds
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hyperglycemia focused on measuring Cyclocarya paliurus extract, hyperglycemia, pre-diabetes and diabetes
Eligibility Criteria
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.
Sites / Locations
- Shiyan Taihe Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
placebo
Cyclocarya paliurus extract
Cyclocarya paliurus compounds
Arm Description
corn starch；capsule，2 g/day，2 times/day；3 months
aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months
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
Outcomes
Primary Outcome Measures
changes of FPG
fasting plasma glucose
changes of HbA1c
glycated hemoglobin
changes of fasting insulin
changes of OGTT
oral glucose tolerance test
Secondary Outcome Measures
changes of blood lipids
total cholesterol，high density lipoprotein cholesterol，low density lipoprotein cholesterol，triglyceride
changes of gut microbiota
16s RNA sequencing
changes of short chain fatty acids
metabolites of microbiota in feces
Full Information
NCT ID
NCT04184440
First Posted
November 21, 2019
Last Updated
December 1, 2019
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04184440
Brief Title
The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
Official Title
The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Cyclocarya paliurus extract, hyperglycemia, pre-diabetes and diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be divided randomly into three groups，among which the intervention will start and end simultaneously.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
corn starch；capsule，2 g/day，2 times/day；3 months
Arm Title
Cyclocarya paliurus extract
Arm Type
Experimental
Arm Description
aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months
Arm Title
Cyclocarya paliurus compounds
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Cyclocarya paliurus extract
Intervention Description
The participants are divided randomly into three groups，one of which are asked to Cyclocarya paliurus extract for three months .
Intervention Type
Dietary Supplement
Intervention Name(s)
Cyclocarya paliurus compounds
Intervention Description
The participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months .
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
The participants are divided randomly into three groups，one of which are asked to take placebo for three months .
Primary Outcome Measure Information:
Title
changes of FPG
Description
fasting plasma glucose
Time Frame
at 0 week，4th week and 12th week in the intervention period
Title
changes of HbA1c
Description
glycated hemoglobin
Time Frame
at 0 week，4th week and 12th week in the intervention period
Title
changes of fasting insulin
Time Frame
at 0 week，4th week and 12th week in the intervention period
Title
changes of OGTT
Description
oral glucose tolerance test
Time Frame
at 0 week，4th week and 12th week in the intervention period
Secondary Outcome Measure Information:
Title
changes of blood lipids
Description
total cholesterol，high density lipoprotein cholesterol，low density lipoprotein cholesterol，triglyceride
Time Frame
at 0 week，4th week and 12th week in the intervention period
Title
changes of gut microbiota
Description
16s RNA sequencing
Time Frame
at 0 week，4th week and 12th week in the intervention period
Title
changes of short chain fatty acids
Description
metabolites of microbiota in feces
Time Frame
at 0 week，4th week and 12th week in the intervention period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liegang Liu, PhD
Phone
+86-27-83650522
Email
liegangliu@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hongjie Liu, master
Email
D201981405@hust.edu.cn
Facility Information:
Facility Name
Shiyan Taihe Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442008
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liegang Liu, PhD
Phone
+86-27-83650522
Email
liegangliu@gmail.com
First Name & Middle Initial & Last Name & Degree
Hongjei Liu, master
Email
D201981405@hust.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
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