NCT00485056

Brief Summary

This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the effects of insulin-sensitizing agent pioglitazone, on heart and artery function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Apr 2008

Typical duration for phase_4 diabetes

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

First Submitted

Initial submission to the registry

June 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2009

Enrollment Period

2 years

First QC Date

June 11, 2007

Last Update Submit

August 8, 2016

Conditions

Diabetes

Keywords

DiabetesTissue doppler imagingWave intensity analysis.

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be the TDI E' ratio which is the relatively preload independent measure of ventricular diastolic function.

    26 weeks

Secondary Outcomes (1)

  • E/E' measured by TDI (a non-invasive measure of preload).

    26 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Crossover arm

Drug: Pioglitazone

Pioglitazone

ACTIVE COMPARATOR

Pioglitazone 45mgs daily

Drug: Pioglitazone

Interventions

PioglitazoneDRUG

45mgs daily

PioglitazonePlacebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female of any age with Type 2 Diabetes

You may not qualify if:

  • Subjects will be excluded if they have any of the following:
  • Known coronary heart disease,
  • Patients receiving Insulin,
  • Uncontrolled hypertension (i.e. \>160mmHg systolic or \>95mmHg diastolic),
  • Systolic dysfunction (ejection fraction \<50%),
  • Heart Valve Disease,
  • Proliferative or pre-proliferative retinopathy,
  • Severe hepatic or renal impairment.
  • Possible pregnancy
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Circulatory Health

London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alun D Hughes, phd

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 12, 2007

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 9, 2016

Record last verified: 2009-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)