Clinical trial NCT00728403: Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes
Official title: Long Term Metabolic and Therapeutic Effects of Combined Treatment of American Ginseng (Panax Quinquefolius L.) Extract and Korean Red Ginseng (Steamed Panax C.A. Meyer) Extract in the Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2008-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a 2 phase double blind randomized placebo control trial. The objective is to asses the metabolic and therapeutic effects of American Ginseng (Panax quinquefolius L.) extract and Korean Red Ginseng (steamed Panax C.A. Meyer) extract in the management of type 2 diabetes in a 12 week period. One Hundred and twenty subjects with type 2 diabetes (hyperglycemia key inclusion criteria: HbAlc≥6.5% - ≤ 8.1% ) will participate in the study (36 men and 36 post-menopausal women).


Eligibility criteria: Inclusion Criteria:

* presence of type 2 diabetes (at least 1 year) as defined by A1c between ≥6.5% and ≤8.1%, at recruitment,
* treatment with diet or oral hypoglycemic medication be unchanged starting at least 2 months prior to the beginning of the study (at recruitment, week -8)
* between the age of 40 and 75 years
* systolic blood pressure \<140 and diastolic blood pressure \<90
* clinically euthyroid (measuring T3 and T4)
* normal renal and liver functions
* post-menopausal or non-pregnant women (Post-menopausal includes: those females with more than a year of cessation of menstruation)
* a negative result on a pregnancy test administered at screening
* subjects taking an effective form of birth control (example: condom, abstinence, etc.)
* willing to comply with the study protocol and sign a consent form

Exclusion Criteria:

* individuals with bleeding disorders
* individuals with allergies to nitroglycerin
* planned surgery, pregnancy or breastfeeding
* taking insulin; clinically significant diabetes complications (retinopathy, nephropathy, or neuropathy); serum triglycerides ≥ 4.5 mmol/L
* increased A1c level of more than 2% from baseline during the study
* history of angina or heart attack
* use of ginseng or any natural health products with glucose modulating and/or anti-platelet activity within 2 months
* BMI \> 35 kg/m2 including a weight fluctuation of + 2kg during treatment periods
* smoke cigarettes; alcohol intake \> 2 drinks/day
* the presence of any conditions which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel or adversely affect the study results, if the subject participated in the study
* Subjects taking Warfarin or Coumadin, prescription NSAIDs, chronic use of high-dose (\>81mg) non-prescription NSAIDs, or selective serotonin reuptake inhibitors and monoamine oxidase inhibitors, or sympathomimetics or medications affecting nitric oxide levels, or any known or suspected sensitivity to any of the ingredients in the test product or placebo cannot participate in the study.

Primary outcomes:
measure: HbA1c levels and insulin sensitivity index using 3 different indices: ISI, HOMA, QUICKI
timeFrame: Weeks -4, 0, 6, 12
Secondary outcomes:
measure: Cholesterol, triglycerides, fasting & post-prandial blood glucose and insulin, C-reactive protein, lipid peroxidation, blood pressure, endothelial function, body fat composition
timeFrame: Weeks -4, 0, 6, 12
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Clinical Nutrition and Risk Factor Modification Centre
state: Ontario
Study officials:
affiliation: Clinical Nutritian and Risk Factor Modification Centre
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Nutrition and Risk Factor Modificatrion Centre
name: Alexandra Jenkins, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michaels Hospital
name: Lawerence Leiter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Nutrition and Risk Factor Modificatrion Centre
name: Leanne De Souza, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: