The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

Hyperglycemia Clinical Trial

Official title:

The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04184440
• Other study ID #: QQLY2019
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: July 2020

Study information

• Verified date: December 2019
• Source: Huazhong University of Science and Technology
• Contact: Liegang Liu, PhD
• Phone: +86-27-83650522
• Email: liegangliu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Dietary Supplement:
• Cyclocarya paliurus extract
The participants are divided randomly into three groups,one of which are asked to Cyclocarya paliurus extract for three months .
• Cyclocarya paliurus compounds
The participants are divided randomly into three groups,one of which are asked to take Cyclocarya paliurus compounds for three months .
• placebo
The participants are divided randomly into three groups,one of which are asked to take placebo for three months .

Locations

Country	Name	City	State
China	Shiyan Taihe Hospital	Shiyan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of FPG	fasting plasma glucose	at 0 week,4th week and 12th week in the intervention period
Primary	changes of HbA1c	glycated hemoglobin	at 0 week,4th week and 12th week in the intervention period
Primary	changes of fasting insulin		at 0 week,4th week and 12th week in the intervention period
Primary	changes of OGTT	oral glucose tolerance test	at 0 week,4th week and 12th week in the intervention period
Secondary	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
Secondary	changes of gut microbiota	16s RNA sequencing	at 0 week,4th week and 12th week in the intervention period
Secondary	changes of short chain fatty acids	metabolites of microbiota in feces	at 0 week,4th week and 12th week in the intervention period