Diabetes Mellitus Type 2, Hypertension
Conditions
Brief summary
The study is a combined Phase-I like (safety) and Phase-II like (efficacy) double blind randomized placebo controlled trial. The objective is to investigate whether the combination of AG and Rg3-enriched Korean Red ginseng added to conventional medical treatment are effective and safe in the long-term management of high blood pressure while managing type 2 diabetes. Eighty-five subjects with type 2 diabetes and concomitant high blood pressure (key inclusion criteria: HbA1c ≥ 6.5%- ≤ 8.0%) will be recruited for the study.
Interventions
DIETARY_SUPPLEMENTGinseng
2.25g of encapsulated ginseng (1.5g American Ginseng and 0.75g Rg3-enriched Korean Red Ginseng)will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
DIETARY_SUPPLEMENTWheat Bran
2.25g of encapsulated 100% natural wheat bran will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
Sponsors
Canadian Diabetes Association
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* between the age of 40 and 75 years * type 2 diabetes (at least 1 year duration, HbA1c ≥ 6.5%- ≤ 8.0%, treated with diet and/or oral hypoglycemic medications) * clinically diagnosed and treated hypertension according to Canadian Diabetes Association Clinical Practice Guidelines * normal thyroid, kidney and liver functions * female subjects recruited for the study must be post-menopausal or had absence of menstruation for ≥ 1 year or is taking contraceptive precautions
Exclusion criteria
* insulin therapy * history of angina, myocardial infarction or stroke * systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg * use of ginseng within 1 month start of study * BMI \>35 kg/m2 * smoking cigarettes * alcohol intake of \> 2 drinks/day * recently given blood * have an upcoming planned surgery * GFR \<60 mL/min/1.73m2 * prolonged QT (\>20 ms) interval as assessed by ECG * changes to use of natural health products that may effect blood pressure and/or diabetes * weight change more than +/- 3 kg/month * HIV infection, inflammatory bowel disease, celiac disease, heart disease, bleeding disorder, sleep disorder, arrhythmia * pregnant or breastfeeding * use of anticoagulant (excluding aspirin), antiplatelet, sedative, sympathomimetic, photosensitizing or anti-depressant drugs * hormone replacement therapy, furosemide, morphine, glucocorticoids * presence of any conditions which, in the opinion of the Qualified Investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results * known sensitivity or allergy to any test product or placebo ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks | 12 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulse Pressure | 12 Weeks | — |
| Change in Central Augmentation Index and pulse wave analysis | 12 Weeks | — |
| Change in Pulse Wave Velocity at 12 Weeks | 12 Weeks | — |
| Change in low-grade body inflammation (hs-CRP) | 12 Weeks | — |
| Change in HbA1c | 12 Weeks | — |
| Change in Mean 24 hour Diastolic, daytime and nighttime Ambulatory Blood pressure at 12 Weeks | 12 Weeks | — |
| Change in Fasting Glucose | 12 Weeks | — |
| Change in Calculated HOMA-Insulin Sensitivity | 12 Weeks | — |
| Change in RHI at 12 weeks | 12 weeks | vs control |
| Change in lipids at 12 weeks | 12 weeks | vs control |
| Change in Fasting Insulin | 12 Weeks | — |
Countries
Canada, Croatia
Outcome results
None listed