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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00237588 |
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Date of registration:
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10/10/2005 |
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Primary sponsor: |
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Public title:
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Glucose Optimisation With Angiotensin II Antagonist Losartan (GOAAL)
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Scientific title:
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Glucose Optimisation With Angiotensin II Antagonist Losartan in Patients With Hypertension and Other Risk Factors for Metabolic Syndrome (GOAAL) |
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Date of first enrolment:
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December 2004 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00237588 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind
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Countries of recruitment
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Norway
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Contacts
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Name:
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Sverre E Kjeldsen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ullevaal University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: Amlodipine 10 mg or Losartan 100 mg + Amlodipine 5 mg
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Primary Outcome(s)
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Insulin sensitivity assessed with hyperinsulinaemic isoglycaemic glucose clamp(GDR)
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Secondary Outcome(s)
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Adipocytokines etc.(Adiponectin, leptin, resistin, TNF-a, PAI-1 activity, ghrelin)
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Baroreflex sensitivitiy
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C-peptide
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Catecholamines
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Fasting serum glucose
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Fasting serum insulin
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Heart rate variability
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High sensitivity C-reactive protein
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HOMA-IR
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Lipids (Triglycerides, Total-cholesterolHDL-cholesterol, LDL-cholesterol)
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Microalbuminuria
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Serum uric acid
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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