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Combined Rg3-enriched Korean Red Ginseng and American Ginseng in the Management of Hypertension in Type 2 Diabetes (R-KAT)

This study is currently recruiting participants.
Verified February 2013 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
Vladimir Vuksan, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01578837
First received: April 12, 2012
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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 ≥ 7.0%- ≤ 8.0%) will be recruited for the study.


Condition Intervention Phase
Diabetes Mellitus Type 2
Hypertension
 Dietary Supplement: Ginseng
Dietary Supplement: Wheat Bran
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Combined Rg3-enriched Korean Red Ginseng (Panax Ginseng C.A. Meyer) and American Ginseng (Panax Quinquefolius) as Poly-therapy in the Management of Concomitant Hypertension in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Change from Baseline in Mean 24 hour Systolic Ambulatory Blood Pressure at 12 weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Mean 24 hour Diastolic Ambulatory Blood pressure at 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Pulse Pressure [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Central Augmentation Index [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Pulse Wave Velocity at 12 Weeks [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in low-grade body inflammation (hs-CRP) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in HbA1c [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Fasting Insulin [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Fasting Glucose [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in Calculated HOMA-Insulin Sensitivity [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ginseng
Combined Rg3-enriched Korean Red Ginseng and American Ginseng capsule
 Dietary Supplement: Ginseng
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).
Placebo Comparator: Wheat Bran
100 % Natural Wheat Bran capsule
 Dietary Supplement: Wheat 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).

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between the age of 40 and 75 years
  • type 2 diabetes (at least 1 year duration, HbA1c ≥ 7.0%- ≤ 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578837

Contacts
Contact: Elena Jovanovski, MSc. 416-864-6060 ext 2597 JovanovskiE@smh.ca
Contact: Allison Komishon, MSc.(c) 416-864-6060 ext 5527 KomishonA@smh.ca

Locations
Canada, Ontario
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Elena Jovanovski, MSc.     416-864-6060 ext 2597     JovanovskiE@smh.ca    
Contact: Allison Komishon, MSc.(c)     416-864-6060 ext 5527     KomishonA@smh.ca    
Principal Investigator: Vladimir Vuksan, PhD            
Sub-Investigator: Robert Josse (Qualified Investigator), MD,FRCP(C)            
Sub-Investigator: Kamel S Kamel, M.B.B.Ch,FRCP(C)            
Sub-Investigator: John Sievenpiper, M.D., PhD            
Sub-Investigator: Mi-Kyung Sung, PhD            
Sub-Investigator: Alexandra Jenkins, PhD, RD            
Croatia
Dubrava University Hospital Not yet recruiting
Zagreb, Croatia, 10000
Contact: Dario Rahelic, M.D., PhD     ++38512902444     drahelic@kbd.hr    
Principal Investigator: Dario Rahelic, M.D., PhD            
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Diabetes Association
Investigators
Principal Investigator: Vladimir Vuksan, PhD Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
  More Information

No publications provided

Responsible Party: Vladimir Vuksan, Dr. Vladimir Vuksan, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01578837     History of Changes
Other Study ID Numbers: OG-2-09-2920-VV
Study First Received: April 12, 2012
Last Updated: February 21, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013