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Completed

NCT Number: NCT00131846

Diuretics In the Management of Essential Hypertension (DIME) Study

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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Key information

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of the Ryukyus

Nishihara, Okinawa, 903-0215, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiazide diuretics

Drug

Any dosage, frequency, and duration

No diuretics

Drug

Any antihypertensive regimen other than diuretics

Primary outcomes

  1. New onset type 2 diabetes (WHO criteria 1998)

    Time frame: five years

Secondary outcomes

  1. Treatment resistant hypokalemia less than 3.5mEq/L

    Time frame: five years

  2. Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes

    Time frame: five years

  3. Myocardial infarction

    Time frame: five years

  4. Hospitalization due to heart failure

    Time frame: five years

  5. Arteriosclerosis obliterans (ASO)

    Time frame: five years

  6. Total death

    Time frame: five years

  7. Blood pressure

    Time frame: five years

  8. Lipid profile

    Time frame: five years

  9. HbA1c

    Time frame: five years

  10. Fasting blood sugar

    Time frame: five years

  11. Direct Cost

    Time frame: five years

  12. Gout (American College of Rheumatology 1997 criteria C)

    Time frame: five years

Sponsors and collaborators

Lead sponsor

Kyoto University

Other

Collaborators

  • University of the Ryukyus

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2012
Study completion
2013
First posted
Aug 19, 2005
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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