Glucose Optimisation With Angiotensin II Antagonist Losartan (GOAAL)

NCT00237588 | Completed Phase 4

• 1 other identifier: 308-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Angiotensin II Type I Receptor Blockers; Amlodipine; Calcium Channel Blockers; Diabetes Mellitus; Hypertension; Insulin Resistance; Losartan

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity assessed with hyperinsulinaemic isoglycaemic glucose clamp(GDR)

Secondary Outcomes (12)

• Fasting serum glucose

• Fasting serum insulin

• HOMA-IR

• C-peptide

• High sensitivity C-reactive protein

Interventions

Amlodipine 10 mg or Losartan 100 mg + Amlodipine 5 mg DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ullevaal University Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

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

Oslo, 0407, Norway

Location

Related Publications (1)

• 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.

  PMID: 16988754 RESULT

Related Links

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

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Insulin Resistance

Interventions

Amlodipine; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Tetrazoles

Study Officials

• Sverre E Kjeldsen, MD, PhD

  Ullevaal University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2005
• First Posted: October 12, 2005
• Study Start: December 1, 2004
• Study Completion: July 1, 2005
• Last Updated: July 6, 2011

Record last verified: 2005-10

Locations

NO (1)