Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Pycnogenol®, a natural product, a "complementary or alternative medicine", will reduce the use of antihypertensive medicines (Angiotensin Converting Enzyme [ACE] inhibitors) and Cardiovascular Disease (CVD) risk factors in subjects with both hypertension and type 2 diabetes.
Ethics approval
Ethics approval received from the Human Subjects Protection Program at University of Arizona on the 16th August 2003 (ref: 03-129).
Study design
Single-centre, interventional, randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular risk factors in diabetes
Intervention
Oral administration of Pycnogenol® pills (25 mg, 5 times a day) or matched inactive placebo for 12 weeks. Total duration of follow-up is 15 weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
Pycnogenol®
Primary outcome measures
Measured at 12th week of treatment:
1. Blood pressure, measured on the left arm after 10 minutes rest (Korotkoff sounds I and V were taken as the systolic and diastolic blood pressures)
2. Serum endothelin-1
3. Fasting Low Density Lipoprotein (LDL)-cholesterol
4. Glycosylated haemoglobin (HbA1c)
5. Fasting plasma glucose
6. Urinary albumin concentration
Secondary outcome measures
Measured at 4th and 8th week of treatment:
1. Blood pressure, measured on the left arm after 10 minutes rest (Korotkoff sounds I and V were taken as the systolic and diastolic blood pressures)
2. Serum endothelin-1
3. Fasting Low Density Lipoprotein (LDL)-cholesterol
4. Glycosylated haemoglobin (HbA1c)
5. Fasting plasma glucose
6. Urinary albumin concentration
Overall trial start date
01/08/2003
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Men and women, 40 - 75 years of age
2. Non-insulin dependent type 2 diabetes
3. Receiving pharmaceutical treatment (ACE-inhibitors) for hypertension
4. Pre-trial systolic blood pressure of 130 - 150 mmHg
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Type 1 diabetes
2. Use of insulin
3. Any supplements other than single daily multivitamin
4. Having any major illness such as cancer, asthma, or heart failure
5. Any previous cardiac events
6. Pregnancy, or being nursing mother
Recruitment start date
01/08/2003
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United States of America
Trial participating centre
Mel and Enid Zuckerman College of Public Health
Tucson
85724-5155
United States of America
Sponsor information
Organisation
Horphag Research Ltd (Switzerland)
Sponsor details
P.O. Box 80
Avenue Louis-Casai 71
Cointrin
Geneva
CH-1216
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Horphag Research Ltd (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary