The "metabolic syndrome" is a cluster of metabolic and cardiovascular risk factors. Insulin resistance appears to be a central disease mechanism and hypertension is another important component. A typical patient is characterized by abdominal obesity, glucose intolerance, dyslipidemia and often hypertension. Other associated conditions are disturbancies of coagulation, fibrinolysis, and endothelial function as well as markers of inflammation.
Conditions
Interventions
Trade Name: Atacand, 16 mg, tabletter
Product Name: Atacand
Pharmaceutical Form: Tablet
INN or Proposed INN: Candesartan cilexetil
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
Umeå University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients between 18 and 70 years old with: - hypertension diagnosed or treated since three months or more. Blood pressure at visit 2 equal to or more than 140/90 but not above 170/105 mmHg. (Visit 2 is the randomization visit. The patients have then been on placebo hypertensive treatment for a varying period of time. Blood pressure has been measured every two weeks). - abdominal obesity difines as waist circumference greater than or equal to 102 cm (males) or 88 cm (females) - written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Uncontrolled hypertension, treated or non-treated with a SP >170 or DP >105 mmHg (at screening or during the placebo run-in period) - Diabetes mellitus, previously diagnosed or indicated by fasting or 2h OGTT plasma glucose levels - Any history of coronary heart or cerebrovascular disease - Cardiac failure at stages NHYA II-IV - Severe liver disease (e.g. ASAT and/or ALAT >3* upperlimit of normal range) - Modest-severe impairment in renal function (S-creatinine >150 micromol/L) - Uncontrolled endocrine disorders - Previous (within 5 years) or ongoing malignancy - Recent or ongoing alcohol or drug abuse (within 6 months before screening) - Ongoing or recent treatment wiwth fibrates (within 2 months) - Ongoing treatment with antiobesity drugs - Ongoing systemic treatment with ant-inflammatory drugs, NSAIDs and steroids - Pregnancy (or in non post-menopausal females) insufficient anticonception - Received an investigational drug within 2 months prior to screening - Any disease that according to teh investigator could be adversely affected by the study - Any patient that the investigator considers unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure and compare the effect of 12 weeks treatment with three different regimens (candesartan, hydrochlorothiazid and placebo) on insulin sensitivity assessed by hyperinsulinemic euglycemic clamp.;Secondary Objective: To measure and compare the effects of 12 weeks on candesartan, hydrochlorothiazid and placebo on: - beta cell function - vascular/endothelial function - lipolysis regulation - autonomic nerve activity - abdominal fat tissue distribution - amount of lean body and fat mass - liver and muscle fat - interaction between insulin and AT-II in fat metabolism - fat cell gene expression -adipokine levels;Primary end point(s): In this short term experimental study thera are no other endpoints than the measurements at specified points in time | — |
Countries
Sweden
Outcome results
None listed