HypertensionPhase 4NCT00131846
Diuretics In the Management of Essential Hypertension (DIME) Study
A Phase 4 study testing Thiazide diuretics and No diuretics in people with Hypertension, run by Kyoto University at 1 site in Japan.
Trial summary
The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Thiazide diuretics and No diuretics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,130 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2004to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 30 to 79 years
- With blood pressure being >150/>90 if they are not on any antihypertensive treatment
- With blood pressure being >140/>90 if they are already on antihypertensive drugs
- No history of type 2 diabetes
- No history of gout
Who cannot join
- With supine blood pressure being >200/>120
- Patients already on antihypertensive treatment if duration of treatment and drugs used are not identified
- Patients already on thiazide diuretics
- With type 2 diabetes
- With gout or hyperuricaemia (>8.0 mg/dl)
- With hypokalemia（<3.5mmol/L）
Show all 16Show fewer
- With erectile dysfunction
- With renal dysfunction (s-creatinine > 2.0 mg/dL)
- With history of serious adverse reaction to thiazide diuretics
- With history of stroke or myocardial infarction within 6 months
- With history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 6 months or in whom these interventions are planned
- With heart failure or left ventricular dysfunction (ejection fraction<40%)
- Patients who should be on thiazide diuretics
- With history of malignant tumor within 5 years
- Pregnant, possibility of pregnancy, or during breast feeding
- Patients who are deemed not eligible for this study for any reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Dose Thiazide Diuretics on New Onset Type 2 Diabetes in Patients With Essential Hypertension
The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives, effective in reduction of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an equivalence trial.
Read the detailed description
There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. Diuretics may be more effective in reduction of blood pressure in Japanese patients than Caucasian because of higher salt intake. Moreover, given a large number of hypertensive population here, diuretics may be the most cost-effective antihypertensive agent. Japanese physicians, however, tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes, which is deemed to increase cardiovascular risk. Although it is unlikely that use of low dose (12.5 mg of HCTZ or less) diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents (e.g. Ca antagonist, ACE inhibitor, ARB, K sparing diuretics) other than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in Japanese, who are assumed to be "diabetes prone" based upon thrifty gene hypothesis.
- Conditions
- Hypertension
- Being tested
- Thiazide diuretics, No diuretics
- Keywords
- Thiazide diuretics, Essential hypertension, Type 2 diabetes, Randomized clinical trial, Cost-effectiveness
- Medical subject headings
- Hypertension, Essential Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiazide diureticsDrug
Any dosage, frequency, and duration
No diureticsDrug
Any antihypertensive regimen other than diuretics
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Diuretics use Receives: Drug: Thiazide diuretics |
| 2 | Active comparator | No diuretics use Receives: Drug: No diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
New onset type 2 diabetes (WHO criteria 1998)
Measured: five years
Secondary outcomes (12)
Treatment resistant hypokalemia less than 3.5mEq/L
Measured: five years
Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes
Measured: five years
Myocardial infarction
Measured: five years
Hospitalization due to heart failure
Measured: five years
Arteriosclerosis obliterans (ASO)
Measured: five years
Total death
Measured: five years
Blood pressure
Measured: five years
Lipid profile
Measured: five years
HbA1c
Measured: five years
Fasting blood sugar
Measured: five years
Direct Cost
Measured: five years
Gout (American College of Rheumatology 1997 criteria C)
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startApr 2004
- Primary completionAug 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Ryukyus
- Responsible party
- Principal investigator, Takeshi Morimoto, Kyoto University
- Investigators
- Shinichiro Ueda, MB, ChB, PhD, Principal investigator, Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131846
- Sponsor's protocol ID
- H15-choju-003
- Status last verified
- Jun 2024
- First submitted
- 17 Aug 2005
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ueda S, Morimoto T, Ando S, Takishita S, Kawano Y, Shimamoto K, Ogihara T, Saruta T; DIME Investigators. A randomised controlled trial for the evaluation of risk for type 2 diabetes in hypertensive patients receiving thiazide diuretics: Diuretics In the Management of Essential hypertension (DIME) study. BMJ Open. 2014 Jul 16;4(7):e004576. doi: 10.1136/bmjopen-2013-004576.
PubMed 25031188
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Dose Thiazide Diuretics on New Onset Type 2 Diabetes in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT00131846
- Acronym / sponsor ID
- H15-choju-003
- Conditions
- Hypertension
- Keywords
- Thiazide diuretics, Essential hypertension, Type 2 diabetes, Randomized clinical trial, Cost-effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,130 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Collaborators
- University of the Ryukyus
- Study start
- Apr 2004 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives, effective in reduction of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an equivalence trial.
Detailed description
There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. Diuretics may be more effective in reduction of blood pressure in Japanese patients than Caucasian because of higher salt intake. Moreover, given a large number of hypertensive population here, diuretics may be the most cost-effective antihypertensive agent. Japanese physicians, however, tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes, which is deemed to increase cardiovascular risk. Although it is unlikely that use of low dose (12.5 mg of HCTZ or less) diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents (e.g. Ca antagonist, ACE inhibitor, ARB, K sparing diuretics) other than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in Japanese, who are assumed to be "diabetes prone" based upon thrifty gene hypothesis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Thiazide diureticsDiuretics use |
| 2 | Active comparator | Drug: No diureticsNo diuretics use |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 30 to 79 years
- With blood pressure being >150/>90 if they are not on any antihypertensive treatment
- With blood pressure being >140/>90 if they are already on antihypertensive drugs
- No history of type 2 diabetes
- No history of gout
Key exclusion criteria (16 listed)
- With supine blood pressure being >200/>120
- Patients already on antihypertensive treatment if duration of treatment and drugs used are not identified
- Patients already on thiazide diuretics
- With type 2 diabetes
- With gout or hyperuricaemia (>8.0 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiazide diureticsAny dosage, frequency, and duration | Drug | 1 |
| No diureticsAny antihypertensive regimen other than diuretics | Drug | 2 |
Primary outcome
New onset type 2 diabetes (WHO criteria 1998)
Time frame: five years
12 secondary outcomes
Treatment resistant hypokalemia less than 3.5mEq/L
Time frame: five years
Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes
Time frame: five years
Myocardial infarction
Time frame: five years
Hospitalization due to heart failure
Time frame: five years
Arteriosclerosis obliterans (ASO)
Time frame: five years
Total death
Time frame: five years
Blood pressure
Time frame: five years
Lipid profile
Time frame: five years
HbA1c
Time frame: five years
Fasting blood sugar
Time frame: five years
Direct Cost
Time frame: five years
Gout (American College of Rheumatology 1997 criteria C)
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Derived from this study: PubMed 25031188Ueda S, Morimoto T, Ando S, Takishita S, Kawano Y, Shimamoto K, Ogihara T, Saruta T; DIME Investigators. A randomised controlled trial for the evaluation of risk for type 2 diabetes in hypertensive patients receiving thiazide diuretics: Diuretics In the Management of Essential hypertension (DIME) study. BMJ Open. 2014 Jul 16;4(7):e004576. doi: 10.1136/bmjopen-2013-004576.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shinichiro Ueda, MB, ChB, PhD principal investigator
Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thiazide diuretics and No diuretics in people with Hypertension, run by Kyoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New onset type 2 diabetes (WHO criteria 1998) (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131846, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.