Status:
COMPLETED
Glucose Optimisation With Angiotensin II Antagonist Losartan (GOAAL)
Lead Sponsor:
Ullevaal University Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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 effect...
Eligibility Criteria
Inclusion
- Essential hypertension with diastolic blood pressure 95-110 mmHg and systolic blood pressure \< 180 mmHg
- Previously untreated hypertension or treated with monotherapy (but not with ACE-inhibitors or Angiotensin II-receptor blockers)
- Impaired glucose tolerance or impaired fasting glucose (fasting plasma glucose; 6.1-7.0 mmol/l (110-126 mg/dl)
- Age over 18
- Informed consent
- Any one of these: Microalbuminuria (urin excretion \>20 microg/min), dyslipidemia (HDL-cholesterol \<0.9 mmol/l(35 mg/dl), Triglycerides \> 1.7 mmol/l (150 mg/dl), waist to hip-ratio \>0.9 in men and \>0.85 in women, BMI \>28 kg/m2.
Exclusion
- Previous or current use of ACE-inhibitors or Angiotensin II-receptor blockers
- Previous or current antidiabetic medications
- "Brittle" pre-diabetes where the investigator anticipates pharmacological treatment within next 6 months
- Hypertensive patients where the investigator anticipates polytherapy within next 6 months
- Female patient who is pregnant or nursing or planning pregnancy within the duration of the study
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00237588
Start Date
December 1 2004
End Date
July 1 2005
Last Update
July 6 2011
Active Locations (1)
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1
Cardiovascular and Renal Research Center/ Department of Cardiology, Ullevaal University Hospital
Oslo, Norway, 0407