Comparison of effects of combined angiotensin converting enzyme inhibitor and low dose thiazide diuretic on insulin action in patients with hypertension and type two diabetes: a double-blind crossover study
| ISRCTN | ISRCTN41655008 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41655008 |
| Protocol serial number | 203/01 |
| Sponsor | Royal Victoria Hospital (UK) |
| Funders | Metabolic Research fund - Royal Victoria Hospital, Belfast, N.Ireland (UK), Royal Fellowship - Royal Victoria Hospital (UK) |
- Submission date
- 19/12/2006
- Registration date
- 06/02/2007
- Last edited
- 03/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Regional Centre for Endocrinology
Level One
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
| patrick.bell@royalhospitals.n-i.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind crossover study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Research Ethics Committee, Royal Victoria Hospital on behalf of Queens University Belfast on 22/082001(ref: 203/01) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Captopril and bendroflumethiazide |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Serum potassium was significantly lower after treatment with captopril and bendroflumethiaizide as compared to treatment with captopril alone. |
| Completion date | 01/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2001 |
| Date of final enrolment | 01/04/2004 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
BT12 6BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
