Diuretics In the Management of Essential Hypertension (DIME) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Kyoto University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of the Ryukyus
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University
ClinicalTrials.gov Identifier:
NCT00131846
First received: August 17, 2005
Last updated: August 22, 2012
Last verified: August 2012

August 17, 2005
August 22, 2012
January 2004
December 2012   (final data collection date for primary outcome measure)
New onset type 2 diabetes (WHO criteria 1998) [ Time Frame: five years ] [ Designated as safety issue: Yes ]
New onset type 2 diabetes
Complete list of historical versions of study NCT00131846 on ClinicalTrials.gov Archive Site
  • Treatment resistant hypokalemia less than 3.5mEq/L [ Time Frame: five years ] [ Designated as safety issue: Yes ]
  • Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes [ 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 ]
  • Direct Cost [ Time Frame: five years ] [ Designated as safety issue: No ]
  • Gout (American College of Rheumatology 1997 criteria C) [ Time Frame: five years ] [ Designated as safety issue: Yes ]
  • Gout
  • Treatment resistant hypokalemia
  • Stroke
  • Myocardial infarction
  • Hospitalization due to heart failure
  • ASO
  • Total death
  • Blood pressure
  • Lipid profile
  • HbA1c
  • Fasting blood sugar
  • Cost
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Hypertension
  • Drug: Thiazide diuretics
    Any dosage, frequency, and duration
  • Drug: No diuretics
    Any antihypertensive regimen other than diuretics
  • Active Comparator: 1
    Diuretics use
    Intervention: Drug: Thiazide diuretics
  • Active Comparator: 2
    No diuretics use
    Intervention: Drug: No diuretics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1130
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00131846
H15-choju-003
Yes
Takeshi Morimoto, Kyoto University
Kyoto University
University of the Ryukyus
Principal Investigator: Shinichiro Ueda, MB, ChB, PhD Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus
Kyoto University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP