NCT00131846

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,130 (actual)
• Sponsor: Kyoto University · Academic / Other
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Thiazide diuretics	Any dosage, frequency, and duration
DRUG	No diuretics	Any antihypertensive regimen other than diuretics

Timeline

• Start date: 2004-04-01
• Primary completion: 2012-08-01
• Completion: 2013-11-01
• First posted: 2005-08-19
• Last updated: 2024-06-14

Locations

1 site across 1 country: Japan