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AzTrials

Type II Diabetes ControlPhase 2NCT02923453

Effect of Ginseng in Type 2 Diabetes

A Phase 2 study testing CNT 2000 American ginseng extract in people with Type II Diabetes Control, run by Unity Health Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A total of 23 type 2 patients are enrolled in the study. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Type II Diabetes Control
What is being tested?
CNT 2000 American ginseng extract
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteCanada
Study dates
Mar 1998to Aug 2002
Phase
Phase 2
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of type 2 diabetes of ≥1 year duration
  • BMI between 25-35kg/m^2
  • HbA1c between 6.5-8.5%

Who cannot join

  • Patients on insulin therapy
  • Impaired hepatic or renal function
  • Clinically manifested diabetic complications
  • Present cardiac problems
  • Uncontrolled hypoglycemia
  • Cigarette smokers
Show all 10Show fewer
  • Alcohol consumption (>2 drinks per week)
  • Taking ginseng or other herb with possible hypoglycemic effect
  • Involvement in any other investigational drug studies
  • Changed medication during the course of the study periods or during the washout period

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • : Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: Efficacy and Safety of American Ginseng (Penax Quinquefolius) Extract on Glycemic Control in Individuals With Type 2 Diabetes: A Double-blind, Randomized, Crossover Clinical Trial

Objective: We aim to evaluate longer term efficacy and safety of AG as an add-on therapy in patients with type 2 diabetes controlled by conventional treatment. Materials and Methods: A total of 23 type 2 patients are enrolled in the study. Utilizing a double-blind, crossover design, the participants are randomized to receive either placebo or American ginseng extract (AG) 1g/meal=3g/day for 8-week, while maintained on their conventional diabetes treatment. Following ≥4-week washout period the participants are crossed over to another 8-week treatment arm. Throughout the study period, all individuals maintain their original diabetes treatment and regular lifestyle. The primary endpoint is HbA1c, and secondary are fasting blood glucose and insulin, blood pressure, serum nitrates/nitrites (NOx) and PAI-1. Safety parameters include liver, kidney and hemostatic functions.

Being tested
CNT 2000 American ginseng extract, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CNT 2000 American ginseng extractDietary supplement

  • PlaceboDietary supplement

Study groups in NCT02923453
Study groupRoleWhat they receive
PlaceboPlacebo comparator1g/meal of placebo three times per day (3g/day) for 8-weeks.
Receives: Dietary Supplement: Placebo
Ginseng ExtractActive comparatorCNT2000 (Chai-Na- Ta Corp., Langley, BC) American ginseng extract 1g/meal of placebo three times per day (3g/day) for 8-weeks.
Receives: Dietary Supplement: CNT 2000 American ginseng extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Measured: 8 weeks

Secondary outcomes (7)

  1. Fasting blood glucose

    Measured: 8 weeks

  2. Fasting blood insulin

    Measured: 8 weeks

  3. Blood pressure

    Measured: 8 weeks

  4. serum nitrates/nitrites (NOx)

    Measured: 8 weeks

  5. Plasminogen activator inhibitor-1 (PAI-1)

    Measured: 8 weeks

  6. Alanine amino-transferase (ALT)

    Measured: 8 weeks

  7. serum creatinine

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2016 (estimated)
  2. Study startMar 1998
  3. Primary completionDec 2001
  4. Study completionAug 2002

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02923453
Sponsor's protocol ID
CNT 2000
Status last verified
Oct 2016
First submitted
3 Oct 2016
Last updated
4 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Van Gaal L, Scheen A. Weight management in type 2 diabetes: current and emerging approaches to treatment. Diabetes Care. 2015 Jun;38(6):1161-72. doi: 10.2337/dc14-1630.

    PubMed 25998297

  • Bacon L, Aphramor L. Weight science: evaluating the evidence for a paradigm shift. Nutr J. 2011 Jan 24;10:9. doi: 10.1186/1475-2891-10-9.

    PubMed 21261939

  • Bravata DM, Sanders L, Huang J, Krumholz HM, Olkin I, Gardner CD, Bravata DM. Efficacy and safety of low-carbohydrate diets: a systematic review. JAMA. 2003 Apr 9;289(14):1837-50. doi: 10.1001/jama.289.14.1837.

    PubMed 12684364

  • Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. doi: 10.1001/jama.293.1.43.

    PubMed 15632335

  • Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.

    PubMed 19246357

  • Post RE, Mainous AG 3rd, King DE, Simpson KN. Dietary fiber for the treatment of type 2 diabetes mellitus: a meta-analysis. J Am Board Fam Med. 2012 Jan-Feb;25(1):16-23. doi: 10.3122/jabfm.2012.01.110148.

    PubMed 22218620

  • Johnston BC, Kanters S, Bandayrel K, Wu P, Naji F, Siemieniuk RA, Ball GD, Busse JW, Thorlund K, Guyatt G, Jansen JP, Mills EJ. Comparison of weight loss among named diet programs in overweight and obese adults: a meta-analysis. JAMA. 2014 Sep 3;312(9):923-33. doi: 10.1001/jama.2014.10397.

    PubMed 25182101

  • Buckley JD, Howe PRC. Long-chain omega-3 polyunsaturated fatty acids may be beneficial for reducing obesity-a review. Nutrients. 2010 Dec;2(12):1212-1230. doi: 10.3390/nu2121212. Epub 2010 Dec 9.

    PubMed 22254005

  • Valdivia-Lopez MA, Tecante A. Chia (Salvia hispanica): A Review of Native Mexican Seed and its Nutritional and Functional Properties. Adv Food Nutr Res. 2015;75:53-75. doi: 10.1016/bs.afnr.2015.06.002. Epub 2015 Aug 5.

    PubMed 26319904

  • Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8.

    PubMed 17686832

  • Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.

    PubMed 4337382

  • Bazinet RP, McMillan EG, Cunnane SC. Dietary alpha-linolenic acid increases the n-3 PUFA content of sow's milk and the tissues of the suckling piglet. Lipids. 2003 Oct;38(10):1045-9. doi: 10.1007/s11745-006-1159-9.

    PubMed 14669969

  • Katsuki A, Urakawa H, Gabazza EC, Murashima S, Nakatani K, Togashi K, Yano Y, Adachi Y, Sumida Y. Circulating levels of active ghrelin is associated with abdominal adiposity, hyperinsulinemia and insulin resistance in patients with type 2 diabetes mellitus. Eur J Endocrinol. 2004 Nov;151(5):573-7. doi: 10.1530/eje.0.1510573.

    PubMed 15538935

  • Chandran M, Phillips SA, Ciaraldi T, Henry RR. Adiponectin: more than just another fat cell hormone? Diabetes Care. 2003 Aug;26(8):2442-50. doi: 10.2337/diacare.26.8.2442. No abstract available.

    PubMed 12882876

  • Guo Y, Ma L, Enriori PJ, Koska J, Franks PW, Brookshire T, Cowley MA, Salbe AD, Delparigi A, Tataranni PA. Physiological evidence for the involvement of peptide YY in the regulation of energy homeostasis in humans. Obesity (Silver Spring). 2006 Sep;14(9):1562-70. doi: 10.1038/oby.2006.180.

    PubMed 17030967

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CNT 2000 American ginseng extract in people with Type II Diabetes Control, 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 4 Oct 2016. 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. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HbA1c (time frame: 8 weeks). 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 NCT02923453, which also lists 38 linked publications.

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 4 Oct 2016.

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