Impaired Glucose ToleranceNCT01841229
Effect of Ginseng on Glycemic Control
An observational study of Impaired Glucose Tolerance and Diabetes, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Ginseng (American ginseng, Asian ginseng, Korean ginseng etc) is expected to show positive hypoglycemic effects, including improvements in glycated blood proteins[HbA1c], fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance [HOMA-IR]). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Impaired Glucose Tolerance, Diabetes
- How many people
- 770 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to May 2013
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Diabetic (type 1 \& type 2) Pre-diabetic Hypertensive Healthy
Who may be able to join
- Dietary trials in humans
- Randomized treatment allocation
- 1 month
- Suitable control
- Viable endpoint data
Who cannot join
- Non-human studies
- Non-randomized treatment allocation
- <1 month
- Lack of a suitable control
- No viable endpoint data
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Toronto 3D Knowledge Synthesis and Clinical trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St.Michael's Hospital.
Toronto, Ontario, M5C 2T2
About this study
Official title: Effect of Ginseng on Glycemic Control: A Systematic Review and Meta-analysis of Controlled Trials to Provide Evidence-based Clinical Recommendations
Ginseng (American ginseng, Asian ginseng, Korean ginseng etc) is expected to show positive hypoglycemic effects, including improvements in glycated blood proteins[HbA1c], fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance [HOMA-IR]).
Read the detailed description
Ginseng has demonstrated to have significant hypoglycemic effect. Its major pharmacological component is considered to be ginsenosides. Several trials have been undertaken in diabetes some of which have demonstrated advantages in glycemic control in both diabetic as well as non diabetic individuals although clinical consistency of results is lacking.The lack of high quality data in this area to support diabetes recommendations represents an urgent call for stronger evidence. A systematic review and meta-analysis of controlled trials remains the "Gold Standard" of evidence for recommendations and clinical guidelines development. Therefore, investigators will conduct a systematic review and meta-analyses of controlled trials to assess the effect of ginseng on glycemic control.
- Conditions
- Impaired Glucose Tolerance, Diabetes
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
Measured: 1month
Secondary outcomes (3)
Fasting blood glucose
Measured: 1month
Fasting plasma insulin
Measured: 1 month
Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Observational
- Enrolment
- 770 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vladimir Vuksan, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841229
- Sponsor's protocol ID
- MetaG
- Status last verified
- May 2013
- First submitted
- 23 Apr 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shishtar E, Sievenpiper JL, Djedovic V, Cozma AI, Ha V, Jayalath VH, Jenkins DJ, Meija SB, de Souza RJ, Jovanovski E, Vuksan V. The effect of ginseng (the genus panax) on glycemic control: a systematic review and meta-analysis of randomized controlled clinical trials. PLoS One. 2014 Sep 29;9(9):e107391. doi: 10.1371/journal.pone.0107391. eCollection 2014.
PubMed 25265315
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ginseng on Glycemic Control: A Systematic Review and Meta-analysis of Controlled Trials to Provide Evidence-based Clinical Recommendations
- ClinicalTrials.gov ID
- NCT01841229
- Acronym / sponsor ID
- MetaG
- Conditions
- Impaired Glucose Tolerance, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 770 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 26 Apr 2013 (estimated)
- 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.
Ginseng (American ginseng, Asian ginseng, Korean ginseng etc) is expected to show positive hypoglycemic effects, including improvements in glycated blood proteins[HbA1c], fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance [HOMA-IR]).
Detailed description
Ginseng has demonstrated to have significant hypoglycemic effect. Its major pharmacological component is considered to be ginsenosides. Several trials have been undertaken in diabetes some of which have demonstrated advantages in glycemic control in both diabetic as well as non diabetic individuals although clinical consistency of results is lacking.The lack of high quality data in this area to support diabetes recommendations represents an urgent call for stronger evidence. A systematic review and meta-analysis of controlled trials remains the "Gold Standard" of evidence for recommendations and clinical guidelines development. Therefore, investigators will conduct a systematic review and meta-analyses of controlled trials to assess the effect of ginseng on glycemic control.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetic (type 1 \& type 2) Pre-diabetic Hypertensive Healthy
Key inclusion criteria (5 listed)
- Dietary trials in humans
- Randomized treatment allocation
- 1 month
- Suitable control
- Viable endpoint data
Key exclusion criteria (5 listed)
- Non-human studies
- Non-randomized treatment allocation
- <1 month
- Lack of a suitable control
- No viable endpoint data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glycated hemoglobin (HbA1c)
Time frame: 1month
3 secondary outcomes
Fasting blood glucose
Time frame: 1month
Fasting plasma insulin
Time frame: 1 month
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
- Derived from this study: PubMed 25265315Shishtar E, Sievenpiper JL, Djedovic V, Cozma AI, Ha V, Jayalath VH, Jenkins DJ, Meija SB, de Souza RJ, Jovanovski E, Vuksan V. The effect of ginseng (the genus panax) on glycemic control: a systematic review and meta-analysis of randomized controlled clinical trials. PLoS One. 2014 Sep 29;9(9):e107391. doi: 10.1371/journal.pone.0107391. eCollection 2014.
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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.
Vladimir Vuksan, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impaired Glucose Tolerance and Diabetes, run by Unity Health Toronto at 1 site in Canada.
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 5 inclusion and 5 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 23 May 2013. 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 Canada. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (HbA1c) (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01841229, which also lists 1 linked publication.
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 23 May 2013.