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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18445178
Publication citations
-
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.