- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00131846
Diuretics In the Management of Essential Hypertension (DIME) Study
March 14, 2017 updated by: Takeshi Morimoto, Kyoto University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1130
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Okinawa
-
Nishihara-cho, Okinawa, Japan, 903-0215
- University of the Ryukyus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Diuretics use
|
Any dosage, frequency, and duration
|
Active Comparator: 2
No diuretics use
|
Any antihypertensive regimen other than diuretics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
New onset type 2 diabetes (WHO criteria 1998)
Time Frame: five years
|
five years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treatment resistant hypokalemia less than 3.5mEq/L
Time Frame: five years
|
five years
|
Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes
Time Frame: five years
|
five years
|
Myocardial infarction
Time Frame: five years
|
five years
|
Hospitalization due to heart failure
Time Frame: five years
|
five years
|
Arteriosclerosis obliterans (ASO)
Time Frame: five years
|
five years
|
Total death
Time Frame: five years
|
five years
|
Blood pressure
Time Frame: five years
|
five years
|
Lipid profile
Time Frame: five years
|
five years
|
HbA1c
Time Frame: five years
|
five years
|
Fasting blood sugar
Time Frame: five years
|
five years
|
Direct Cost
Time Frame: five years
|
five years
|
Gout (American College of Rheumatology 1997 criteria C)
Time Frame: five years
|
five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shinichiro Ueda, MB, ChB, PhD, Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2004
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
August 17, 2005
First Submitted That Met QC Criteria
August 17, 2005
First Posted (Estimate)
August 19, 2005
Study Record Updates
Last Update Posted (Actual)
March 15, 2017
Last Update Submitted That Met QC Criteria
March 14, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H15-choju-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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