Glucose Optimisation With Angiotensin II Antagonist Losartan (GOAAL)

NCT ID: NCT00237588

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-07-31

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.

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Interventions

Amlodipine 10 mg or Losartan 100 mg + Amlodipine 5 mg

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Sverre E Kjeldsen, MD, PhD

Role: STUDY_DIRECTOR

Ullevaal University Hospital

Locations

Cardiovascular and Renal Research Center/ Department of Cardiology, Ullevaal University Hospital

Oslo, , Norway

Countries

Norway

References

Aksnes TA, Reims HM, Guptha S, Moan A, Os I, Kjeldsen SE. Improved insulin sensitivity with the angiotensin II-receptor blocker losartan in patients with hypertension and other cardiovascular risk factors. J Hum Hypertens. 2006 Nov;20(11):860-6. doi: 10.1038/sj.jhh.1002087. Epub 2006 Sep 21.

Reference Type: RESULT

PMID: 16988754 (View on PubMed)

Related Links

http://www.cvr.no

Homepage for Cardiovascular and Renal Research Center, Ullevaal University Hospital, Oslo, Norway

Other Identifiers

308-1

Identifier Type: -

Identifier Source: org_study_id