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

Sponsor:	Kyoto University
Collaborator:	University of the Ryukyus
Information provided by:	Kyoto University
ClinicalTrials.gov Identifier:	NCT00131846

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

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

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines Diabetes High Blood Pressure

U.S. FDA Resources

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

No publications provided

Responsible Party:	University of Ryukyus School of medicine ( Shinichiro Ueda )
Study ID Numbers:	H15-choju-003
Study First Received:	August 17, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00131846 History of Changes
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

Additional relevant MeSH terms:

Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors

Diuretics
Vascular Diseases
Cardiovascular Diseases
Pharmacologic Actions
Hypertension

ClinicalTrials.gov processed this record on November 09, 2009