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Diuretics In the Management of Essential Hypertension (DIME) Study

Effect of Low Dose Thiazide Diuretics on New Onset Type 2 Diabetes in Patients With Essential Hypertension

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131846
Enrollment
1130
Registered
2005-08-19
Start date
2004-04-30
Completion date
2013-11-30
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Thiazide diuretics, Essential hypertension, Type 2 diabetes, Randomized clinical trial, Cost-effectiveness

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.

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.

Interventions

Any dosage, frequency, and duration

DRUGNo diuretics

Any antihypertensive regimen other than diuretics

Sponsors

University of the Ryukyus
CollaboratorOTHER
Kyoto University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
New onset type 2 diabetes (WHO criteria 1998)five years

Secondary

MeasureTime frame
Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causesfive years
Myocardial infarctionfive years
Hospitalization due to heart failurefive years
Arteriosclerosis obliterans (ASO)five years
Total deathfive years
Treatment resistant hypokalemia less than 3.5mEq/Lfive years
Lipid profilefive years
HbA1cfive years
Fasting blood sugarfive years
Direct Costfive years
Gout (American College of Rheumatology 1997 criteria C)five years
Blood pressurefive years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026