Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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. (see Contacts and Locations)
Verified February 2014 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 18, 2014
Last verified: February 2014
  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 ≥ 6.5%- ≤ 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:


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: June 2015
Estimated Primary Completion Date: December 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 ≥ 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 18, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 23, 2014