Pioglitazone on Cardiac Function and Large Arteries (PICCOLA Study) (PICCOLA)

August 8, 2016 updated by: Imperial College London

Pioglitazone on Cardiac Function and Large Arteries (PICCOLA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of diabetes mellitus and impaired glucose tolerance are nearing epidemic proportions in developed societies. For example in the USA >16 million individuals have diabetes and this number is predicted to double over the next two decades. Diabetes is a major risk factor for death and disability, primarily from cardiovascular disease (CVD).

The mechanisms of how diabetes increases the risk of developing CVD are not fully understood. It is evident from previous studies that diabetes has an adverse effect on both artery and heart function. What is emerging from recent studies is that it is likely that these proven dysfunctions in the arteries and heart interact to increase the risk of CVD.

Insulin-sensitizing agents, such as Pioglitazone, may have a beneficial effect on heart and artery function. This study aims to further our understanding of the effect of these agents on heart and artery using a novel, sensitive, non-invasive scanning technique to investigate the effects of this group of drugs on heart and artery function.

This is a prospective double-blind randomised crossover study comparing the insulin-sensitizing drug, Pioglitazone with a placebo in 24 volunteers. Following a >1 week run-in period subjects will be randomised double-blind to 1 of 2 treatment sequences. Subjects will either receive the active drug (Pioglitazone 45mg/day) for a 12 week period, followed by a 2 week washout and then the placebo drug for 12 weeks OR they will receive the placebo drug for 12 weeks, followed by the 2 week washout and 12 weeks of the active drug (Pioglitazone 45mg/day).

This design was chosen to test the null hypothesis that the active drug will have no effect on diastolic heart function. The use of a placebo is essential to ensure that any benefits found can be attributed to the active drug. The design also allows us to minimise the number of subjects needed and is the gold standard approach to avoid observer bias.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1PG
        • International Centre for Circulatory Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female of any age with Type 2 Diabetes

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Crossover arm
Drug: Pioglitazone
45mgs daily
Active Comparator: Pioglitazone
Pioglitazone 45mgs daily
Drug: Pioglitazone
45mgs daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint will be the TDI E' ratio which is the relatively preload independent measure of ventricular diastolic function.
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
E/E' measured by TDI (a non-invasive measure of preload).
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Alun D Hughes, phd, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 11, 2007

First Submitted That Met QC Criteria

June 11, 2007

First Posted (Estimate)

June 12, 2007

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU-IIT-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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