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Glucose Optimisation With Angiotensin II Antagonist Losartan (GOAAL)
This study has been completed.
Sponsors and Collaborators: Ullevaal University Hospital
Merck
Information provided by: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00237588
  Purpose

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 Intervention Phase
Hypertension
Drug: Amlodipine 10 mg or Losartan 100 mg + Amlodipine 5 mg
Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Insulin Calcium gluconate Dextrose Losartan Losartan potassium Amlodipine Amlodipine besylate Angiotensin II Angiotensin II, ile(5)-
U.S. FDA Resources
Study Type: Interventional
Study Design: Educational/Counseling/Training, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title: Glucose Optimisation With Angiotensin II Antagonist Losartan in Patients With Hypertension and Other Risk Factors for Metabolic Syndrome (GOAAL)

Further study details as provided by Ullevaal University Hospital:

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

Secondary Outcome Measures:
  • Fasting serum glucose
  • Fasting serum insulin
  • HOMA-IR
  • C-peptide
  • 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
  • Catecholamines
  • Baroreflex sensitivitiy
  • Heart rate variability
  • Microalbuminuria

Estimated Enrollment: 25
Study Start Date: December 2004
Estimated Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237588

Locations
Norway
Cardiovascular and Renal Research Center/ Department of Cardiology, Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Merck
Investigators
Study Director: Sverre E Kjeldsen, MD, PhD Ullevaal University Hospital
  More Information

Homepage for Cardiovascular and Renal Research Center, Ullevaal University Hospital, Oslo, Norway  This link exits the ClinicalTrials.gov site
Homepage for Cardiovascular and Renal Research Center, Ullevaal University Hospital, Oslo, Norway  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: 308-1
Study First Received: October 10, 2005
Last Updated: November 2, 2006
ClinicalTrials.gov Identifier: NCT00237588  
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Ullevaal University Hospital:
Angiotensin II Type I Receptor Blockers
Amlodipine
Calcium Channel Blockers
Diabetes Mellitus
Hypertension
Insulin Resistance
Losartan

Study placed in the following topic categories:
Calcium, Dietary
Losartan
Vascular Diseases
Diabetes Mellitus
Insulin Resistance
Angiotensin II
Insulin
Amlodipine
Hypertension

Additional relevant MeSH terms:
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Vasoconstrictor Agents
Calcium Channel Blockers
Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009