NCT00131846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,130

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

8.3 years

First QC Date

August 17, 2005

Last Update Submit

June 12, 2024

Conditions

Hypertension

Keywords

Thiazide diureticsEssential hypertensionType 2 diabetesRandomized clinical trialCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • New onset type 2 diabetes (WHO criteria 1998)

    five years

Secondary Outcomes (12)

  • Treatment resistant hypokalemia less than 3.5mEq/L

    five years

  • Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes

    five years

  • Myocardial infarction

    five years

  • Hospitalization due to heart failure

    five years

  • Arteriosclerosis obliterans (ASO)

    five years

  • +7 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Diuretics use

Drug: Thiazide diuretics

2

ACTIVE COMPARATOR

No diuretics use

Drug: No diuretics

Interventions

Thiazide diureticsDRUG

Any dosage, frequency, and duration

1
No diureticsDRUG

Any antihypertensive regimen other than diuretics

2

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the Ryukyus

Nishihara, Okinawa, 903-0215, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25031188DERIVED

MeSH Terms

Conditions

HypertensionEssential HypertensionDiabetes Mellitus, Type 2

Interventions

Sodium Chloride Symporter Inhibitors

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesDiureticsNatriuretic AgentsPhysiological Effects of Drugs

Study Officials

  • Shinichiro Ueda, MB, ChB, PhD

    Department of Clinical Pharmacology & Therapeutics, University of the Ryukyus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 19, 2005

Study Start

April 1, 2004

Primary Completion

August 1, 2012

Study Completion

November 1, 2013

Last Updated

June 14, 2024

Record last verified: 2024-06

Locations

JP(1)