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| Descriptive Information Fields | |||||||||
| Brief Title † | Diuretics In the Management of Essential Hypertension (DIME) Study | ||||||||
| Official Title † | Effect of Low Dose Thiazide Diuretics on New Onset Type 2 Diabetes in Patients With Essential Hypertension | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study | ||||||||
| Primary Outcome Measure † | New onset type 2 diabetes [ Time Frame: five years ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Treatment resistant hypokalemia [ Time Frame: five years ] [ Designated as safety issue: Yes ] Stroke [ Time Frame: five years ] [ Designated as safety issue: No ] Myocardial infarction [ Time Frame: five years ] [ Designated as safety issue: No ] Hospitalization due to heart failure [ Time Frame: five years ] [ Designated as safety issue: No ] Arteriosclerosis obliterans (ASO) [ Time Frame: five years ] [ Designated as safety issue: No ] Total death [ Time Frame: five years ] [ Designated as safety issue: No ] Blood pressure [ Time Frame: five years ] [ Designated as safety issue: No ] Lipid profile [ Time Frame: five years ] [ Designated as safety issue: No ] HbA1c [ Time Frame: five years ] [ Designated as safety issue: Yes ] Fasting blood sugar [ Time Frame: five years ] [ Designated as safety issue: Yes ] Cost [ Time Frame: five years ] [ Designated as safety issue: No ] Gout [ Time Frame: five years ] [ Designated as safety issue: Yes ] |
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| Condition † | Hypertension | ||||||||
| Intervention † | Drug: Thiazide diuretics Drug: No diuretics |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 1800 | ||||||||
| Start Date † | January 2004 | ||||||||
| Completion Date | December 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 30 Years to 79 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Japan | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00131846 | ||||||||
| Organization ID | H15-choju-003 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Kyoto University | ||||||||
| Collaborators †† | University of the Ryukyus | ||||||||
| Investigators † |
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| Information Provided By | Kyoto University | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | August 17, 2005 | ||||||||
| Last Updated Date | June 2, 2008 | ||||||||
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