Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2006
Date assigned
06/02/2007
Last edited
03/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Patrick Bell

ORCID ID

Contact details

Regional Centre for Endocrinology
Level One
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
patrick.bell@royalhospitals.n-i.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

203/01

Study information

Scientific title

Acronym

Study hypothesis

New blood pressure targets have resulted in increased use of antihypertensive drugs including combinations. This study aimed to establish the safety in terms of insulin sensitivity of a low dose thiazide (bendroflumethiazide 1.25 mg)/Angiotensin Converting Enzyme (ACE) inhibitor combination.

Ethics approval

Research Ethics Committee, Royal Victoria Hospital on behalf of Queens University Belfast on 22/082001(ref: 203/01)

Study design

Randomised double-blind crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Type two diabetes and essential hypertension

Intervention

Patients were commenced on captopril 50 mg twice daily and this continued throughout the trial. Patients were randomly assigned to either bendroflumethiazide 1.25 mg once daily or placebo for twelve weeks before being crossed over to receive the alternate randomly allocated bendroflumethiazide or placebo. Insulin action was assessed at the end of the placebo run-in and at the end of the two treatment periods using an isoglycaemic hyperinsulinameic clamp technique.

Intervention type

Drug

Phase

Not Specified

Drug names

Captopril and bendroflumethiazide

Primary outcome measures

When compared to captopril alone, treatment with low dose bendroflumethiaizide (1.25 mg) in combination with captopril produced a 23% reduction in glucose infusion rates required to maintain isoglycaemia and there was a comparable reduction in isotopically induced decline in peripheral insulin sensitivity most probably in skeletal muscle. The combination of low-dose bendroflumethiazide 1.25 mg and captopril resulted in a significant reduction in blood pressure (6/3 mmHg) compared to captopril alone.

Secondary outcome measures

Serum potassium was significantly lower after treatment with captopril and bendroflumethiaizide as compared to treatment with captopril alone.

Overall trial start date

01/08/2001

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 40 to 65 years
2. Hypertension (either newly diagnosed or controlled on treatment)
3. Type two diabetes established on dietary treatment with or without oral hypoglycaemic agents
4. Fasting plasma glucose in the range 7 - 12 mmol/l

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

15

Participant exclusion criteria

1. Secondary hypertension
2. Hepatic or renal disease or were taking Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or steroids which may affect insulin action

Recruitment start date

01/08/2001

Recruitment end date

01/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Regional Centre for Endocrinology
Belfast
BT12 6BA
United Kingdom

Sponsor information

Organisation

Royal Victoria Hospital (UK)

Sponsor details

c/o Professor Patrick Bell
Regional Centre for Endocrinology
Level One
Belfast
BT12 6BA
United Kingdom
patrick.bell@royalhospitals.n-i.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.royalhospitals.org/

Funders

Funder type

Research organisation

Funder name

Metabolic Research fund - Royal Victoria Hospital, Belfast, N.Ireland (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Fellowship - Royal Victoria Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18445178

Publication citations

  1. Results

    McLaughlin DM, Atkinson AB, Ennis CN, Browne J, Hunter SJ, Sheridan B, Bell PM, Comparison of effects of combined ACE inhibitor and low-dose thiazide diuretic with ACE inhibitor alone on insulin action in patients with hypertension and Type 2 diabetes: a double-blind crossover study., Diabet. Med., 2008, 25, 5, 631-634, doi: 10.1111/j.1464-5491.2008.02437.x.

Additional files

Editorial Notes