Cardiovascular risk factors in diabetes Circulatory System Cardiovascular risk factors
Conditions
Interventions
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.
Sponsors
Horphag Research Ltd (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States of America
Outcome results
None listed