Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension

NCT00380289 | Unknown

• 1 other identifier: OGTT1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two?

Conditions

Essential Hypertension

Keywords

Essential hypertension; Glucose metabolism; Thiazides; Beta blockers

Outcome Measures

Primary Outcomes (1)

• Can the oral glucose tolerance test detect changes after 4 weeks treatment with thiazide diuretics or beta blockers or combination of the two?

Secondary Outcomes (2)

• Do patients show a similar change in glucose tolerance after thiazide or beta blocker therapy?

• Does the combination of drugs cause a greater reduction in glucose tolerance than expected from the response to each drug taken alone?

Interventions

Thiazide and beta blocker DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers will be aged 18-75 years.
• Hypertension- either
• untreated, BP 140-170/90-110
• treated for over 1 month with drugs other than beta blockers or diuretic and BP\>140/85
• treated for over 1 month with drugs other than beta blockers or diuretic and BP\<140/85 and patient willing to change medication for eight months.

You may not qualify if:

• Any patient already taking thiazide diuretics or beta blockers in whom these drugs cannot be switched to alternative drugs with similar or better blood pressure control.
• Any patient who is intolerant of these medications will be excluded from the study.
• Patients with gout, asthma or any other contraindications to the study drugs will be excluded.
• Women of child bearing age not using contraception.
• Volunteers with heart failure, liver failure, renal failure, terminal illnesses (e.g. cancer)
• Volunteers not able to give informed consent
• Patients with diabetes

Sponsors & Collaborators

• University of Cambridge: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Clinical Pharmacology Unit, Box 110, Level 3 ACCI, Addenbrookes Hospital

Cambridge, CB2 2QQ, United Kingdom

RECRUITING

Related Publications (1)

• Stears AJ, Woods SH, Watts MM, Burton TJ, Graggaber J, Mir FA, Brown MJ. A double-blind, placebo-controlled, crossover trial comparing the effects of amiloride and hydrochlorothiazide on glucose tolerance in patients with essential hypertension. Hypertension. 2012 May;59(5):934-42. doi: 10.1161/HYPERTENSIONAHA.111.189381. Epub 2012 Apr 9.

  PMID: 22493073 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Interventions

Thiazides; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfur Compounds; Organic Chemicals; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Professor MJ Brown, MA MSC MD FRCP

  Addenbrookes Hosptal NHS Trust/ University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor MJ Brown, MA MSC MD FRCP

CONTACT

01223 762577 (UK); mjb14@medschl.cam.ac.uk

Dr A Stears, MBBS BSc MRCP

CONTACT

01223 586865 (UK); as659@medschl.cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 22, 2006
• First Posted: September 25, 2006
• Study Start: September 1, 2006
• Last Updated: September 25, 2006

Record last verified: 2006-09

Locations

GB (1)