Diuretics In the Management of Essential Hypertension (DIME) Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: Thiazide diuretics Drug: No diuretics	Phase IV

MedlinePlus related topics:

Diabetes High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study

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

Further study details as provided by Kyoto University:

Primary Outcome Measures:

New onset type 2 diabetes [ Time Frame: five years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1800
Study Start Date:	January 2004
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Diuretics use	Drug: Thiazide diuretics Any dosage, frequency, and duration
2: Active Comparator No diuretics use	Drug: No diuretics Any antihypertensive regimen other than diuretics

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.

Eligibility

Ages Eligible for Study:	30 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131846

Contacts


Contact: Shinichiro Ueda, MB, ChB, PhD	+81-98-895-1193	suedano9@dream.com

Contact: Shuichio Takishita, MD, PhD	+81-98-895-1148	stakishi@med.u-ryukyu.ac.jp

Locations


Japan, Okinawa
	University of the Ryukyus	Recruiting
	Nishihara-cho, Okinawa, Japan, 903-0215
	Contact: Shinichiro Ueda, MB, ChB, PhD +81-98-895-1193 suedano9@dream.com
	Contact: Shuichio Takishita, MD, PhD +81-98-895-1148 stakishi@med.u-ryukyu.ac.jp
	Principal Investigator: Shinichiro Ueda, MB, ChB, PhD

Sponsors and Collaborators

Kyoto University

University of the Ryukyus

Investigators


Principal Investigator:	Shinichiro Ueda, MB, ChB, PhD	Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus

More Information

Responsible Party:	University of Ryukyus School of medicine ( Shinichiro Ueda )
Study ID Numbers:	H15-choju-003
First Received:	August 17, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00131846
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University:

Thiazide diuretics

Essential hypertension

Type 2 diabetes

Randomized clinical trial

Cost-effectiveness

Study placed in the following topic categories:

Diabetes Mellitus, Type 2

Vascular Diseases

Diabetes Mellitus

Essential hypertension

Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsors and Collaborators:	Kyoto University University of the Ryukyus
Information provided by:	Kyoto University
ClinicalTrials.gov Identifier:	NCT00131846