HyperglycemiaNCT04184440
The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
A study testing Cyclocarya paliurus extract and Cyclocarya paliurus compounds in people with Hyperglycemia, run by Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Cyclocarya paliurus extract and Cyclocarya paliurus compounds
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Mar 2020to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hongjie Liu, master contact
China1 site
Shiyan Taihe Hospital
Shiyan, Hubei, 442008
Liegang Liu, PhD, +86-27-83650522, liegangliu@gmail.com
Hongjei Liu, master, D201981405@hust.edu.cn
About this study
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.
- Conditions
- Hyperglycemia
- Being tested
- Cyclocarya paliurus extract, Cyclocarya paliurus compounds, placebo
- Keywords
- Cyclocarya paliurus extract, hyperglycemia, pre-diabetes and diabetes
- Medical subject headings
- Hyperglycemia, Glucose Intolerance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclocarya paliurus extractDietary supplement
The participants are divided randomly into three groups，one of which are asked to Cyclocarya paliurus extract for three months .
Cyclocarya paliurus compoundsDietary supplement
The participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months .
placeboDietary supplement
The participants are divided randomly into three groups，one of which are asked to take placebo for three months .
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | corn starch；capsule，2 g/day，2 times/day；3 months Receives: Dietary Supplement: placebo |
| Cyclocarya paliurus extract | Experimental | aqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months Receives: Dietary Supplement: Cyclocarya paliurus extract |
| Cyclocarya paliurus compounds | Experimental | 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 Receives: Dietary Supplement: Cyclocarya paliurus compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of FPG
fasting plasma glucose
Measured: at 0 week，4th week and 12th week in the intervention period
changes of HbA1c
glycated hemoglobin
Measured: at 0 week，4th week and 12th week in the intervention period
changes of fasting insulin
Measured: at 0 week，4th week and 12th week in the intervention period
changes of OGTT
oral glucose tolerance test
Measured: at 0 week，4th week and 12th week in the intervention period
Secondary outcomes (3)
changes of blood lipids
total cholesterol，high density lipoprotein cholesterol，low density lipoprotein cholesterol，triglyceride
Measured: at 0 week，4th week and 12th week in the intervention period
changes of gut microbiota
16s RNA sequencing
Measured: at 0 week，4th week and 12th week in the intervention period
changes of short chain fatty acids
metabolites of microbiota in feces
Measured: at 0 week，4th week and 12th week in the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study startMar 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be divided randomly into three groups，among which the intervention will start and end simultaneously.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184440
- Sponsor's protocol ID
- QQLY2019
- Status last verified
- Dec 2019
- First submitted
- 21 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hypoglycemic Effect of Cyclocarya Paliurus Extract on Hyperglycemic Populations
- ClinicalTrials.gov ID
- NCT04184440
- Acronym / sponsor ID
- QQLY2019
- Conditions
- Hyperglycemia
- Keywords
- Cyclocarya paliurus extract, hyperglycemia, pre-diabetes and diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be divided randomly into three groups，among which the intervention will start and end simultaneously.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: placebocorn starch；capsule，2 g/day，2 times/day；3 months |
| Cyclocarya paliurus extract | Experimental | Dietary Supplement: Cyclocarya paliurus extractaqueous extract of Cyclocarya paliurus；capsule，2 g/day，2 times/day；3 months |
| Cyclocarya paliurus compounds | Experimental | Dietary Supplement: Cyclocarya paliurus compoundsmixed 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- type 1 diabetic patients;
- type 2 diabetic patients with insulin treatment；
- pregnant or lactating women；
- adverse effect on intervention；
- acute or chronic inflammatory conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclocarya paliurus extractThe participants are divided randomly into three groups，one of which are asked to Cyclocarya paliurus extract for three months . | Dietary supplement | Cyclocarya paliurus extract |
| Cyclocarya paliurus compoundsThe participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months . | Dietary supplement | Cyclocarya paliurus compounds |
| placeboThe participants are divided randomly into three groups，one of which are asked to take placebo for three months . | Dietary supplement | placebo |
Primary outcome
changes of FPG
Time frame: at 0 week，4th week and 12th week in the intervention period
fasting plasma glucose
changes of HbA1c
Time frame: at 0 week，4th week and 12th week in the intervention period
glycated hemoglobin
changes of fasting insulin
Time frame: at 0 week，4th week and 12th week in the intervention period
changes of OGTT
Time frame: at 0 week，4th week and 12th week in the intervention period
oral glucose tolerance test
3 secondary outcomes
changes of blood lipids
Time frame: at 0 week，4th week and 12th week in the intervention period
changes of gut microbiota
Time frame: at 0 week，4th week and 12th week in the intervention period
changes of short chain fatty acids
Time frame: at 0 week，4th week and 12th week in the intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongjie Liu, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclocarya paliurus extract and Cyclocarya paliurus compounds in people with Hyperglycemia, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liegang Liu, PhD (+86-27-83650522, liegangliu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of FPG (time frame: at 0 week，4th week and 12th week in the intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.