Condition category
Circulatory System
Date applied
18/10/2007
Date assigned
31/10/2007
Last edited
31/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ronald Watson

ORCID ID

Contact details

Mel and Enid Zuckerman College of Public Health
University of Arizona
Health Science Center
1295 N. Martin
P. O. Box 245155 [FedEx building 202 room 252]
Tucson
85724-5155
United States of America

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

http://www.horphag.com

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

Publication citations

Additional files

Editorial Notes