Glucose Optimisation With Angiotensin II Antagonist Losartan (GOAAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237588
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : July 6, 2011
Merck Sharp & Dohme Corp.
Information provided by:
Oslo University Hospital

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 regards to the blood pressure-lowering effect.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine 10 mg or Losartan 100 mg + Amlodipine 5 mg Phase 4

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 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Glucose Optimisation With Angiotensin II Antagonist Losartan in Patients With Hypertension and Other Risk Factors for Metabolic Syndrome (GOAAL)
Study Start Date : December 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Insulin sensitivity assessed with hyperinsulinaemic isoglycaemic glucose clamp(GDR)

Secondary Outcome Measures :
  1. Fasting serum glucose
  2. Fasting serum insulin
  3. HOMA-IR
  4. C-peptide
  5. High sensitivity C-reactive protein
  6. Lipids (Triglycerides, Total-cholesterolHDL-cholesterol, LDL-cholesterol)
  7. Adipocytokines etc.(Adiponectin, leptin, resistin, TNF-a, PAI-1 activity, ghrelin)
  8. Serum uric acid
  9. Catecholamines
  10. Baroreflex sensitivitiy
  11. Heart rate variability
  12. Microalbuminuria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237588

Cardiovascular and Renal Research Center/ Department of Cardiology, Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Merck Sharp & Dohme Corp.
Study Director: Sverre E Kjeldsen, MD, PhD Ullevaal University Hospital

Publications of Results: Identifier: NCT00237588     History of Changes
Other Study ID Numbers: 308-1
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: October 2005

Keywords provided by Oslo University Hospital:
Angiotensin II Type I Receptor Blockers
Calcium Channel Blockers
Diabetes Mellitus
Insulin Resistance

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Angiotensin II
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Vasoconstrictor Agents
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors