Back to resultsDiuretics In the Management of Essential Hypertension (DIME) Study
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Thiazide diuretics
No diuretics
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring Thiazide diuretics, Essential hypertension, Type 2 diabetes, Randomized clinical trial, Cost-effectiveness
Eligibility 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
Sites / Locations
- University of the Ryukyus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Diuretics use
No diuretics use
Outcomes
Primary Outcome Measures
New onset type 2 diabetes (WHO criteria 1998)
Secondary Outcome Measures
Treatment resistant hypokalemia less than 3.5mEq/L
Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes
Myocardial infarction
Hospitalization due to heart failure
Arteriosclerosis obliterans (ASO)
Total death
Blood pressure
Lipid profile
HbA1c
Fasting blood sugar
Direct Cost
Gout (American College of Rheumatology 1997 criteria C)
Full Information
NCT ID
NCT00131846
First Posted
August 17, 2005
Last Updated
March 14, 2017
Sponsor
Kyoto University
Collaborators
University of the Ryukyus
1. Study Identification
Unique Protocol Identification Number
NCT00131846
Brief Title
Diuretics In the Management of Essential Hypertension (DIME) Study
Official Title
Effect of Low Dose Thiazide Diuretics on New Onset Type 2 Diabetes in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2004 (Actual)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University
Collaborators
University of the Ryukyus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Thiazide diuretics, Essential hypertension, Type 2 diabetes, Randomized clinical trial, Cost-effectiveness
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Diuretics use
Arm Title
2
Arm Type
Active Comparator
Arm Description
No diuretics use
Intervention Type
Drug
Intervention Name(s)
Thiazide diuretics
Intervention Description
Any dosage, frequency, and duration
Intervention Type
Drug
Intervention Name(s)
No diuretics
Intervention Description
Any antihypertensive regimen other than diuretics
Primary Outcome Measure Information:
Title
New onset type 2 diabetes (WHO criteria 1998)
Time Frame
five years
Secondary Outcome Measure Information:
Title
Treatment resistant hypokalemia less than 3.5mEq/L
Time Frame
five years
Title
Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes
Time Frame
five years
Title
Myocardial infarction
Time Frame
five years
Title
Hospitalization due to heart failure
Time Frame
five years
Title
Arteriosclerosis obliterans (ASO)
Time Frame
five years
Title
Total death
Time Frame
five years
Title
Blood pressure
Time Frame
five years
Title
Lipid profile
Time Frame
five years
Title
HbA1c
Time Frame
five years
Title
Fasting blood sugar
Time Frame
five years
Title
Direct Cost
Time Frame
five years
Title
Gout (American College of Rheumatology 1997 criteria C)
Time Frame
five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shinichiro Ueda, MB, ChB, PhD
Organizational Affiliation
Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Ryukyus
City
Nishihara-cho
State/Province
Okinawa
ZIP/Postal Code
903-0215
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25031188
Citation
Ueda S, Morimoto T, Ando S, Takishita S, Kawano Y, Shimamoto K, Ogihara T, Saruta T; DIME Investigators. A randomised controlled trial for the evaluation of risk for type 2 diabetes in hypertensive patients receiving thiazide diuretics: Diuretics In the Management of Essential hypertension (DIME) study. BMJ Open. 2014 Jul 16;4(7):e004576. doi: 10.1136/bmjopen-2013-004576.
Results Reference
derived
Learn more about this trial
Diuretics In the Management of Essential Hypertension (DIME) Study
We'll reach out to this number within 24 hrs