Diuretics and Diabetes Control: DIaDIC study
| ISRCTN | ISRCTN03504931 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03504931 |
| Protocol serial number | 2/2013 |
| Sponsor | University of Palermo (Italy) |
| Funders | University of Palermo (Italy), Policlinico "P. Giaccone" - Palermo (Italy), Onlus Nutrition and Health (Associazione Onlus Nutrizione e Salute) (Italy) |
- Submission date
- 20/07/2013
- Registration date
- 01/08/2013
- Last edited
- 01/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diuretics are the most commonly used drugs for the treatment of high blood pressure, even in patients with diabetes. It is known that thiazide and loop diuretics have side effects that favour diabetes. They also usually cause an increase in blood levels of uric acid (hyperuricemia). We are carrying out a study to find out if stopping diuretic treatment and changing to a different drug for high blood pressure may improve glucose tolerance in diabetic and non-diabetic patients. If confirmed, this treatment variation could reduce the occurrence of diabetes, hyperuricemia and the resulting risk of heart disease associated with these conditions.
Who can participate?
At least 80 male and female patients with high blood pressure, aged 30-80 years, including non-diabetic, pre-diabetics and diabetics on diuretic treatment.
What does the study involve?
Participants will be randomly divided into two groups: one group will continue the treatment with diuretics, while for the other group the diuretic will be replaced with a drug called amlodipine. Both groups will be followed for about 6 weeks. At the start of the study and at the end of the follow-up all patients will undergo clinical examinations. In addition, every week participants will either be contacted over telephone or they will have to visit the clinic to regulate the treatment.
What are the possible benefits and risks of participating?
Patients may experience an improvement in glucose metabolism, reducing the risk of heart disease. There are no specific risks and patients will be monitored every week for the whole duration of the study.
Where is the study run from?
The study has been set up by the University of Palermo, Biomedic Department of Internal and Specialistic Medicine (DIBIMIS), Italy.
When is the study starting and how long is it expected to run for?
The study is starting in September 2013 and will last until March 2014.
Who is funding the study?
Funding will be provided by the University of Palermo (Italy), the AOU Policlinico Paolo Giaccone and the non-lucrative Association of Nutrition and Health (Associazione Onlus Nutrizione e Salute), Italy.
Who is the main contact?
Prof. Silvio Buscemi
silbus@tin.it
Contact information
Scientific
Dipartimento Biomedico di medicina Interna e Specialistica (DIBIMIS)
Policlinico "P. Giaccone"
via del vespro, 129
palermo
90127
Italy
| silbus@tin.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized single-blind longitudinal intervention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of withdrawing diuretic therapy (thiazide or loop), used for the treatment of hypertension, on glucose metabolism in subjects with normal glucose tolerance, pre-diabetes or type 2 diabetes: a randomized controlled trial |
| Study objectives | Diuretics (thiazide and loop) have a deleterious effect on glucose tolerance. Discontinuation of anti-hypertensive diuretic treatment may improve glucose tolerance and reduce the hypoglycemic treatment in type 2 diabetics. |
| Ethics approval(s) | Local Ethical Committee of the University Hospital of Palermo (I) approved on the 22th May 2013 (ref. 06/2013) |
| Health condition(s) or problem(s) studied | Hypertension, diabetes, cardiovascular risk |
| Intervention | Evaluation at 6 plus or minus 1 week of the cardiovascular and metabolic effects of two different treatments of hypertension: a) continuation of the previous antihypertensive treatment that includes a diuretic vs. b) replacement of the diuretic with the calcium channel blocker amlodipine (according to a pre-specified flow-chart of dose regulation). Study participants will be assigned to one of two treatment groups randomly. The changes of therapy will be decided by investigators not in direct contact with the participants and those who will carry out the investigations will not be aware of the treatment (single-blinded). Amlodipine 2,5-10 mg orally, once a day vs. hydrochlorotiazide12,5-25 mg or furosemide 10-20 mg orally once a day for 6+/-1 weeks. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amlodipine, hydrochlorotiazide and furosemide |
| Primary outcome measure(s) |
1. Effects on carbohydrates and uric acid metabolism: |
| Key secondary outcome measure(s) |
Effects on cardiovascular and renal performances: |
| Completion date | 31/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Male and female subjects 2. Aged 30-80 years 3. Having hypertension for less than 15 years 4. Basal blood pressure <140/90 mmHg 5. Non diabetics or having diabetes for less than 15 years 6. Using at least one of the following diuretics for more than 6 months: furosemide, torasemide, hydrochlorothiazide, chlorthalidone |
| Key exclusion criteria | 1. Average 24 hour blood pressure from ambulatory blood pressure monitoring > 160/90 mmHg 2. Concomitant use of >3 anti-hypertensives 3. Habitual use of indapamide, spironolactone, calcium channel blockers 4. Habitual use of FANS, corticosteroids, litium salts 5. Allergy or intolerance versus calcium-channel blockers 6. Self monitoring average glycemia > 250 mg/dl 7. Glycated hemoglobin > 86 mol/mol 8. Habitual smokers: more than 10 cigarette/day 9. Habitual use of super-alcoholics or wine more than 1 glass/day 10. Secondary hypertension, congestive heart failure, liver cirrhosis, chronic renal failure (calculated -CKEPI, MDRD - GFR< 40 ml/min/1.73 m2) 11. Connective diseases 12. Severe gastro-oesophageal reflux with Barrett's esofagus 13. Atrioventricular conduction defects 14. Pregnancy or lactation in the last six months 15. Denial of informed consent |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 31/03/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
90127
Italy
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 | 01/12/2013 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
