Glucose Optimisation With Angiotensin II Antagonist Losartan (GOAAL)
To determine if angiotensin-II AT-1 receptor blockade(ARB) may improve insulin sensitivity assessed by the hyperinsulinaemic isoglycaemic glucose clamp, more than CCB therapy at a comparable dose with regards to the blood pressure-lowering effect.
Drug: Amlodipine 10 mg or Losartan 100 mg + Amlodipine 5 mg
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
|Official Title:||Glucose Optimisation With Angiotensin II Antagonist Losartan in Patients With Hypertension and Other Risk Factors for Metabolic Syndrome (GOAAL)|
- Insulin sensitivity assessed with hyperinsulinaemic isoglycaemic glucose clamp(GDR)
- Fasting serum glucose
- Fasting serum insulin
- High sensitivity C-reactive protein
- Lipids (Triglycerides, Total-cholesterolHDL-cholesterol, LDL-cholesterol)
- Adipocytokines etc.(Adiponectin, leptin, resistin, TNF-a, PAI-1 activity, ghrelin)
- Serum uric acid
- Baroreflex sensitivitiy
- Heart rate variability
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||July 2005|
Patients with hypertension have an increased prevalence of insulin resistance and an increased risk of developing diabetes mellitus with ageing. Different antihypertensive regimens have varying effects on glucose metabolism and the development of diabetes mellitus. In a double-blind,randomized cross-over study we aim to compare the metabolic effects of 10 mg amlodipine and 100 mg losartan + 5 mg amlodipine in patients with hypertension and other risk factors for the metabolic syndrome.
After a 4-week open label amlodipine 5 mg run-in period, all hypertensive patient will be randomized to additional treatment with either amlodipine 5 mg or losartan 100 mg for 8 weeks. At the end of this 8-week treatment-period we will do a physical examination, laboratory-tests, hyperinsulinaemic isoglycaemic glucose clamp, heart rate variability and baroreflex sensitivity measurements. Following this is a 4-week wash-out phase where the subjects continue open label 5 mg amlodipine, before crossed over to the opposite treatment regimen for another 8 week before the final examination.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237588
|Cardiovascular and Renal Research Center/ Department of Cardiology, Ullevaal University Hospital|
|Oslo, Norway, 0407|
|Study Director:||Sverre E Kjeldsen, MD, PhD||Ullevaal University Hospital|