Hypertension, Metabolic Syndrome X
Conditions
Keywords
metabolic syndrome, Hypertension, CCB, cilnidipine
Brief summary
Abnormalities of glucose, insulin and lipoprotein metabolism are common in patients with hypertension, and these metabolic abnormalities are reported to be related to insulin resistance. Therefore, whenever treating such patients, antihypertensive agents that may have the added effect of improving insulin resistance should be selected. CinalongTM (Cilnidipine) is expected to improve metabolic syndrome as well as insulin resistance by its dual effects on L and N-type calcium (Ca) channels. In this study, the researchers investigate the effects of CinalongTM on insulin resistance and other metabolic related factors.
Detailed description
* Multi-center, randomized, prospective, double blind, active control, parallel study * Superiority study (Treatment group - Cilnidipine/Control group - Nifedipine) * Measure the effects of Cinalong(TM) after 3 month and 12 month-application
Interventions
DRUGCilnidipine
10\ 20mg, qd, po for 3 months or 12 months.
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Men or women, 30-65 years of age having essential hypertension with metabolic syndrome 2. At Screening and Visit 1, blood pressure should be: sitting systolic blood pressure (SiSBP) \>=140 mmHg or sitting diastolic blood pressure (SiDBP)\>= 90 mmHg and two or more of the following criteria should apply. * Abdominal obesity: waist circumference \>= 90 cm in men and \>= 80 cm in women * Hypertriglyceridemia:. \>=150 mg/dl (1.695 mmol/l) * Low HDL cholesterol: \< 40 mg/dl (1.036 mmol/l) in men and \< 50 mg/dl (1.295 mmol/l) in women * High fasting glucose: \>= 110 mg/dl (6.1 mmol/l)
Exclusion criteria
1. Secondary hypertension 2. Malignant hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Homeostasis model assessment of insulin sensitivity (HOMA-IR) | after 3 month and 12 month treatment |
| Triglyceride/HDL cholesterol ratio | after 3 month and 12 month treatment |
Secondary
| Measure | Time frame |
|---|---|
| Resting norepinephrine | after 3 month and 12 month treatment |
| Change in abdominal obesity | after 3 month and 12 month treatment |
| Change in triglyceride | after 3 month and 12 month treatment |
| Quantitative insulin-sensitivity check index (QUICKI) | after 3 month and 12 month treatment |
| Decrease in trough SiSBP&SiDBP | after 3 month and 12 month treatment |
| Change in blood glucose | after 3 month and 12 month treatment |
| Change in cholesterol | after 3 month and 12 month treatment |
| Resting heart rate | after 3 month and 12 month treatment |
Countries
South Korea
Outcome results
None listed