The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations

Not Applicable

• Conditions: Hyperglycemia
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Cyclocarya paliurus extract; Dietary Supplement: Cyclocarya paliurus compounds

• Registration Number: NCT04184440
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-21
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-01
• Last Update Submitted: 2019-12-01
• Study First Posted: 2019-12-03
• Last Update Posted: 2019-12-03
• Study Start: 2020-03
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	corn starch；capsule，2 g/day，2 times/day；3 months
Cyclocarya paliurus extract	Cyclocarya paliurus extract	aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months
Cyclocarya paliurus compounds	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

Primary Outcome Measures

Name	Time	Method
changes of HbA1c	at 0 week，4th week and 12th week in the intervention period	glycated hemoglobin
changes of FPG	at 0 week，4th week and 12th week in the intervention period	fasting plasma glucose
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 Outcome Measures

Name	Time	Method
changes of short chain fatty acids	at 0 week，4th week and 12th week in the intervention period	metabolites of microbiota in feces
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

Trial Locations

Locations (1)

Shiyan Taihe Hospital; 🇨🇳 Shiyan, Hubei, China