The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

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.

Study Overview

• Status: Unknown
• Conditions: Hyperglycemia
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Cyclocarya paliurus extract; Dietary supplement: Cyclocarya paliurus compounds

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liegang Liu, PhD; Phone Number: +86-27-83650522; Email: liegangliu@gmail.com
• Study Contact Backup: Name: Hongjie Liu, master; Email: D201981405@hust.edu.cn

Study Locations

• China
  • Hubei
    • Shiyan, Hubei, China, 442008
      • Shiyan Taihe Hospital
      • Contact: Liegang Liu, PhD; Phone Number: +86-27-83650522; Email: liegangliu@gmail.com
      • Contact: Hongjei Liu, master; Email: D201981405@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo; corn starch；capsule，2 g/day，2 times/day；3 months	Dietary supplement: placebo; The participants are divided randomly into three groups，one of which are asked to take placebo for three months .
Experimental: Cyclocarya paliurus extract; aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months	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 .
Experimental: Cyclocarya paliurus compounds; 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; The participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months .

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: December 1, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 1, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: hyperglycemia; Cyclocarya paliurus extract; pre-diabetes and diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: QQLY2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No